Commission Implementing Regulation (EU) 2025/1867 of 10 September 2025 granting a Union authorisation for the single biocidal product Sterillium liquid in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

ANNEXSUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT
ANNEX
SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT
Sterillium liquid
Product type(s)
PT01: Human hygiene
Authorisation number: EU-0033788-0000
R4BP asset number: EU-0033788-0000
1.   ADMINISTRATIVE INFORMATION
1.1.    Trade name(s) of the product
Trade name(s)
Sterillium liquid
Manusept liquid
Sterillium pur
1.2.    Authorisation holder
Name and address of the authorisation holder
Name
BODE Chemie GmbH
Address
Melanchthonstr. 27 22525 Hamburg DE
Authorisation number
EU-0033788-0000
R4BP asset number
EU-0033788-0000
Date of the authorisation
5 October 2025
Expiry date of the authorisation
31 July 2032
1.3.    Manufacturer(s) of the product
Name of manufacturer
Bode Chemie GmbH
Address of manufacturer
Melanchthonstrasse 27 22525 Hamburg Germany
Location of manufacturing sites
BODE Chemie GmbH site 1
Melanchthonstraße 27 22525 Hamburg Germany
1.4.    Manufacturer(s) of the active substance(s)
Active substance
Propan-1-ol
Name of manufacturer
OQ Chemicals GmbH (formerly Oxea GmbH)
Address of manufacturer
Rheinpromenade 4a 40789 Monheim am Rhein Germany
Location of manufacturing sites
OQ Chemicals GmbH (formerly Oxea GmbH) site 1
OQ Chemicals Corperation (formerly Oxea Coperation), 2001 FM 3057 TX 77414 Bay City United States (the)
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
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
INEOS Solvent Germany GmbH site 2
INEOS Solvent Germany GmbH, Shamrockstrasse 88 44623 Herne Germany
Active substance
Propan-2-ol
Name of manufacturer
Shell Nederland Raffinaderij B.V.
Address of manufacturer
Vondelingenweg 601 3196 KK Rotterdam-Pernis Netherlands (the)
Location of manufacturing sites
Shell Nederland Raffinaderij B.V. site 1
Shell Nederland Raffinaderij B.V. 3196 KK Rotterdam-Pernis Netherlands (the)
2.   PRODUCT COMPOSITION AND FORMULATION
2.1.    Qualitative and quantitative information on the composition of the product
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-1-ol
active substance
71-23-8
200-746-9
30 % (w/w)
Propan-2-ol
active substance
67-63-0
200-661-7
45 % (w/w)
2.2.    Type(s) of formulation
AL Any other liquid.
3.   HAZARD AND PRECAUTIONARY STATEMENTS
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 authorised waste collection point.
4.   AUTHORISED USE(S)
4.1.    Use description
Table 1
Hygienic handrub, liquid
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: Mycobacteria
Development stage: no data
Scientific name: other
Common name: Yeasts
Development stage: no data
Scientific name: other
Common name: Enveloped viruses
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).
Contact time: 30 seconds.
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, 125, 500, 1 000  ml in high-density polyethylene (HDPE) bottles with polypropylene (PP) flip top caps;
5 000  ml HDPE canister with HDPE screwed cap.
4.1.1.    Use-specific instructions
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.
Do not refill.
4.1.2.    Use-specific risk mitigation measures
See general directions for use under Section 5.2.
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 under Section 5.3.
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use under Section 5.4.
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 under Section 5.5.
4.2.    Use description
Table 2
Surgical handrub, liquid
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: Mycobacteria
Development stage: no data
Scientific name: other
Common name: Yeasts
Development stage: no data
Scientific name: other
Common name: enveloped viruses
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: Rub sufficient amount in portions of 3 ml (use dispensers: for example, set to 1,5 ml per stroke, 2 strokes per 3 ml).
Contact time: 90 seconds.
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, 125, 500, 1 000  ml in high-density polyethylene (HDPE) bottles with polypropylene (PP) flip top caps;
5 000  ml HDPE canister with HDPE screwed cap.
4.2.1.    Use-specific instructions
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.
Do not refill.
4.2.2.    Use-specific risk mitigation measures
See general directions for use under Section 5.2.
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 under Section 5.3.
4.2.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use under Section 5.4.
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 under Section 5.5.
5.   GENERAL DIRECTIONS FOR USE  ( 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
First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention if you feel unwell. If possible, show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
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 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.
Accidental release measures:
Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames. No smoking.
Prevent entry to sewers and public waters.
Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Take up mechanically (sweeping, shoveling). Dispose of in accordance with relevant local regulations.
5.4.    Instructions for safe disposal of the product and its packaging
Disposal must be done according to national legislation. Do not empty into drains. Do not dispose of with domestic waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior to disposal. When totally empty, containers are recyclable like any other packing.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0-30 °C
Do not store at temperatures below 0 °C
Do not store near food, drink and animal feeding stuff. Keep away from combustible material.
6.   OTHER INFORMATION
Not applicable.
( 1 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.
Commission Implementing Regulation (EU) 2025/1867 of 10 September 2025 granting a Union authorisation for the single biocidal product Sterillium liquid in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

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