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)
Article 1
Article 2
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 |
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Authorisation number |
EU-0027675-0000 |
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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 |
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Address of manufacturer |
Kaiser-Wilhelm-Str. 133, 12247 Berlin Germany |
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Location of manufacturing sites |
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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 |
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Name of manufacturer |
INEOS Solvent Germany GmbH |
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Address of manufacturer |
Römerstrasse 733, 47443 Moers Germany |
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Location of manufacturing sites |
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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
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
Product type |
PT01 - Human hygiene (Disinfectants) |
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Where relevant, an exact description of the authorised use |
Not relevant |
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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 |
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Field(s) of use |
Indoor
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Application method(s) |
Method: Manual application Detailed description: Rubbing |
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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:
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Category(ies) of users |
Industrial Professional |
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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
4.1.2.
Use-specific risk mitigation measures
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
4.2.
Use description
Product type |
PT01 - Human hygiene (Disinfectants) |
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Where relevant, an exact description of the authorised use |
Not relevant |
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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 |
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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. |
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Application method(s) |
Method: Manual application Detailed description: Rubbing |
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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:
|
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Category(ies) of users |
Professional |
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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. |