COMMISSION IMPLEMENTING REGULATION (EU) 2023/1105
of 6 June 2023
granting a Union authorisation for the single biocidal product ‘Superficid express WIPES’ 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
Superficid express WIPES
Product type 2 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Product type 4 - Food and feed area (Disinfectants)
Authorisation number: EU-0027676-0000
R4BP asset number: EU-0027676-0000
1.
ADMINISTRATIVE INFORMATION
1.1.
Trade name(s) of the product
Trade name(s) |
Superficid express WIPES Bactesil Wipes IPA Express Wipes Twoalko Express Wipes MicrobaX Express Wipes Alkodes Express Wipes Septokil Express Wipes Mastersept Express Wipes Descoficid Wipes Bactoficid Express Wipes Supergerm Express Wipes Superdes Express Wipes APESIN express F wipes |
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-0027676-0000 |
|
R4BP asset number |
EU-0027676-0000 |
|
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 A.F.P. Antiseptica Forschungs- und Produktionsgesellschaft mbH, Otto-Brenner-Straße 16-18, 21337 Lüneburg Germany Sterisol AB, Kronoängsgatan 3, S 59223 Vadstena Sweden |
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
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 contents to an authorised waste collection point. |
4.
AUTHORISED USE(S)
4.1.
Use description
Product type |
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (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: Yeasts Development stage: no data Scientific name: no data Common name: Enveloped viruses Development stage: no data |
Field(s) of use |
Indoor Health care facilities and pharmaceutical and cosmetic industry, for example patient-near surrounding, working areas/desks, general equipment (excluding food contact surfaces): disinfection of small hard/non-porous surfaces For professional use only. |
Application method(s) |
Method: Manual application Detailed description: Ready-to-use disinfectant wipes at room temperature (20±2 °C). The surface to be disinfected is wiped and wetted with a sufficient amount of the product, ensuring complete Coverage. |
Application rate(s) and frequency |
Application Rate: Minimum exposure time: for the control of bacteria, yeasts and enveloped viruses: 60 sec; Make the surface completely wet. Dilution (%): Ready-to-use product Number and timing of application: A reasonable frequency of disinfection in a patient’s room is 1-2 per day. Maximum number of applications is 6 per day. No safety intervals need to be considered between the application phases. |
Category(ies) of users |
Industrial Professional |
Pack sizes and packaging material |
Dispenser of PE composite foil with screwed-in PE cap, containing 100 PP/PE wipes. |
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 |
PT04 - Food and feed area (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: Yeasts Development stage: no data |
Field(s) of use |
Indoor Health care facilities and food industry, for example patient-near surrounding, food preparation and handling in kitchens/restaurants): disinfection of small hard/non-porous surfaces. For professional use only. |
Application method(s) |
Method: Manual application Detailed description: Ready-to-use disinfectant wipes at room temperature (20±2 °C). The surface to be disinfected is wetted with a sufficient amount of the product by wiping, ensuring complete coverage. |
Application rate(s) and frequency |
Application Rate: Minimum exposure time: for the control of bacteria and yeasts at 20°C: 60 sec; Make the surface completely wet. Dilution (%): Ready-to-use product Number and timing of application: The product can be used as often as necessary. A reasonable frequency of disinfection in kitchens is 1-2 per day. No safety intervals need to be considered between the application phases. |
Category(ies) of users |
Industrial Professional |
Pack sizes and packaging material |
Dispenser of PE composite foil with screwed-in PE cap, containing 100 PP/PE wipes. |