Commission Implementing Regulation (EU) 2023/1106 of 6 June 2023 granting a Union authorisation for the single biocidal product ‘Manorapid express GEL’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)

ANNEXSummary of product characteristics for a biocidal product
ANNEX
Summary of product characteristics for a biocidal product
Manorapid express GEL
Product type 1 - Human hygiene (Disinfectants)
Authorisation number: EU-0027675-0000
R4BP asset number: EU-0027675-0000
1.    ADMINISTRATIVE INFORMATION
1.1.    Trade name(s) of the product
Trade name(s)
Manorapid express GEL
Bactesil Gel
IPA Hands Gel
Twoalko Gel
MicrobaX Gel
Alkodes Gel
Septokil Gel
Mastersept Gel
Bactoficid Gel
Supergerm Gel
Superdes Gel
1.2.    Authorisation holder
Name and address of the authorisation holder
Name
Lysoform Dr. Hans Rosemann GmbH
Address
Kaiser-Wilhelm-Str. 133, 12247 Berlin Germany
Authorisation number
EU-0027675-0000
R4BP asset number
EU-0027675-0000
Date of the authorisation
27 June 2023
Expiry date of the authorisation
31 July 2032
1.3.    Manufacturer(s) of the product
Name of manufacturer
Lysoform Dr. Hans Rosemann GmbH
Address of manufacturer
Kaiser-Wilhelm-Str. 133, 12247 Berlin Germany
Location of manufacturing sites
Lysoform Dr. Hans Rosemann GmbH, Kaiser-Wilhelm-Str. 133, 12247 Berlin Germany
Sterisol AB Kronoängsgatan 3, S 59223 Vadstena Sweden
A.F.P. Antiseptica Forschungs- und Produktionsgesellschaft mbH, Otto-Brenner-Straße 16-18, 21337 Lüneburg 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 Corperation (formerly Oxea Coperation), 2001 FM 3057 TX, 77414 Bay City United States
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, 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, Römerstrasse 733, 47443 Moers Germany
INEOS Solvent Germany GmbH, Shamrockstrasse 88, 44623 Herne Germany
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
14,3
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,14
2.2.    Type of formulation
AL - Any other liquid
3.    HAZARD AND PRECAUTIONARY STATEMENTS
Hazard statements
Highly flammable liquid and vapour.
Causes serious eye damage.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.
Keep container tightly closed.
Avoid breathing vapours.
Use only outdoors or in a well-ventilated area.
IF INHALED:Remove person to fresh air and keep comfortable for breathing.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER/doctor.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of container to an authorised waste collection point.
4.    AUTHORISED USE(S)
4.1.    Use description
Table 1. Use # 1 – hygienic handrub, gel
Product type
PT01 - Human hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Tuberculosis bacilli
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Scientific name: no data
Common name: Enveloped viruses
Development stage: no data
Field(s) of use
Indoor
—
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 s
Dilution (%): 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
125, 150, 500, 1 000 ml in transparent/white high-density polypropylene (HDPE) bottles with polypropylene (PP) flip top caps;
5 000 ml transparent/white HDPE canister with HDPE screwed cap.
700 ml pouch of transparent PE composite foil with integrated PP pump; 75 ml transparent HDPE bottle 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.
Do not refill.
4.1.2.    Use-specific risk mitigation measures
See general directions for use
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
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use
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
4.2.    Use description
Table 2. Use # 2 – surgical handrub, gel
Product type
PT01 - Human hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Tuberculosis bacilli
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Scientific name: no data
Common name: Enveloped viruses
Development stage: no data
Field(s) of use
Indoor
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 s
Dilution (%): 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
125, 150, 500, 1 000 ml in transparent/white high-density polypropylene (HDPE) bottles with polypropylene (PP) flip top caps;
5 000 ml transparent/white HDPE canister with HDPE screwed cap.
700 ml pouch of transparent PE composite foil with integrated PP pump; 75 ml transparent HDPE bottle 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.
Do not refill.
4.2.2.    Use-specific risk mitigation measures
See general directions for use
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
4.2.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use
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
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, shovelling). 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 official regulations. 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 feedingstuff. Keep away from combustible material.
6.    OTHER INFORMATION
( 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) 2023/1106 of 6 June 2023 granting a Union authorisation for the single biocidal product ‘Manorapid express GEL’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)

Schedules & Appendices

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