Commission Implementing Regulation (EU) 2023/1133 of 8 June 2023 granting a Union authorisation for the single biocidal product ‘Superficid express’ 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
Superficid express
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-0027677-0000
R4BP asset number: EU-0027677-0000
1.    ADMINISTRATIVE INFORMATION
1.1.    Trade name(s) of the product
Trade name(s)
Superficid express
Bactesil Express
IPA Express
Twoalko Express
MicrobaX Express
Alkodes Express
Septokil Express
Mastersept Express
Descoficid
Bactoficid Express
Supergerm Express
Superdes Express
Septospace
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-0027677-0000
R4BP asset number
EU-0027677-0000
Date of the authorisation
29 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
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.
Wear eye protection.
Immediately call a POISON CENTER/doctor.
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.
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 – hard non-porous small surface disinfection RTU liquid
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 in 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 surface disinfectant at room temperature (20±2 °C).
The entire surface to be disinfected is wetted by pouring or spraying from short distance and subsequently thoroughly wiped with a cloth. The amount of product should be sufficient (max. 50 ml/m 2 ) to keep the surface wet during the contact time.
Application rate(s) and frequency
Application Rate: Minimum exposure time: • for the control of bacteria,yeasts and enveloped viruses: 60 sec
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
125, 150, 500, 1 000 ml transparent/white high-density polyethylene (HDPE) bottle with polypropylene (PP) flip top caps (accessory: PP screw closure with spray head);
5 000 ml transparent/white HDPE canister with HDPE screwed cap.
4.1.1.    Use-specific instructions for use
Surfaces should always be visibly clean prior to disinfection. Maximum number of applications is 6 per day.
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 – hard non-porous small surface disinfection RTU liquid
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 in food industry, for example 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 surface disinfectant at room temperature (20±2 °C).
The entire surface to be disinfected is wetted by pouring or spraying from short distance and subsequently thoroughly wiped with a cloth. The amount of product should be sufficient (max. 50 ml/m 2 ) to keep the surface wet during the contact time.
Application rate(s) and frequency
Application Rate: Minimum exposure time: for the control of bacteria and yeasts at 20°C: 60 sec
Dilution (%): Ready-to-use product
Number and timing of application:
The products can be used as often as necessary. A reasonable frequency 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
125, 150, 500, 1 000 ml transparent/white high-density polyethylene (HDPE) bottle with polypropylene (PP) flip top caps (accessory: PP screw closure with spray head);
5 000 ml transparent/white HDPE canister with HDPE screwed cap.
4.2.1.    Use-specific instructions for use
Surfaces should always be visibly clean prior to disinfection.
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
The use of eye protection during handling of the product is mandatory.
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) 2023/1133 of 8 June 2023 granting a Union authorisation for the single biocidal product ‘Superficid express’ 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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