Commission Implementing Regulation (EU) 2023/1073 of 1 June 2023 granting a Union authorisation for the single biocidal product ‘Spray On wipes’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)

ANNEX
ANNEX
Summary of product characteristics for a biocidal product
Spray On 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-0027668-0000
R4BP asset number: EU-0027668-0000
1.    ADMINISTRATIVE INFORMATION
1.1.    Trade name(s) of the product
Trade name(s)
Spray On wipes
MyClean DS Tücher plus
MyClean DS Flow Pack plus
MyClean DS Tücher basic
MyClean DS Flow Pack basic
Medizid Rapid Pro Desinfektionstücher
Medizid Rapid QF Pro Flowpack
Medizid Rapid Next Desinfektionstücher
Medizid Rapid QF Next Flowpack
Bavicid Wipe
FAVORIT Wet Wipes Pro
FAVORIT Wet Wipes Classic
FAVORIT Wet Wipes Viruguard
FAVORIT Wet Wipes Pure
FAVORIT Wet Wipes Soft
FAVORIT Wet Wipes Premium
FAVORIT Wet Wipes zero
FAVORIT Wet Wipes Quick
FAVORIT Wet Wipes Maxi
FAVORIT Wet Wipes Protect
FAVORIT Wet Wipes universal
FAVORIT Wet Wipes Basic
FAVORIT Wet Wipes Basic QF
Immix Clean Pro Wipes
FAVORIT Wet Wipes Xtra
1.2.    Authorisation holder
Name and address of the authorisation holder
Name
Laboratorium Dr Deppe GmbH
Address
Hooghe Weg 35, 47906 Kempen Germany
Authorisation number
EU-0027668-0000
R4BP asset number
EU-0027668-0000
Date of the authorisation
22 June 2023
Expiry date of the authorisation
31.7.2032
1.3.    Manufacturer(s) of the product
Name of manufacturer
Laboratorium Dr Deppe GmbH
Address of manufacturer
Hooghe Weg 35, 47906 Kempen Germany
Location of manufacturing sites
Laboratorium Dr Deppe GmbH, Hooghe Weg 35, 47906 Kempen 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-1-ol
Name of manufacturer
SASOL Chemie GmbH & Co. KG
Address of manufacturer
Secunda Chemical Operations, Sasol Place, 50 Katherine Street, 2090 Sandton South Africa
Location of manufacturing sites
Secunda Chemical Operations, PDP Kruger Street, 2302 Secunda South Africa
Active substance
Propan-2-ol
Name of manufacturer
Stockmeier Chemie GmbH & Co. KG
Address of manufacturer
Am Stadtholz 37, 33609 Bielefeld Germany
Location of manufacturing sites
INEOS Solvent Germany GmbH, Römerstrasse 733, 47443 Moers Germany
Active substance
Propan-2-ol
Name of manufacturer
Brenntag GmbH
Address of manufacturer
Stinnes-Platz 1, 45472 Mülheim an der Ruhr Germany
Location of manufacturing sites
Shell Nederland Raffinaderij B.V., 3196 KK Rotterdam-Pernis Netherlands
Exxon Mobil, LA 70805 Baton Rouge United States
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
14,925
Propan-2-ol
Active Substance
67-63-0
200-661-7
44,73
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 contents to an authorised waste collection point.
4.    AUTHORISED USES(S)
4.1.    Use description
Table 1. Use # 1 – hard non-porous small surface disinfection RTU wipes
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:
Scientific name: no data
Common name: Yeasts
Development stage:
Scientific name: no data
Common name: Enveloped viruses
Development stage:
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
Flow-pack of polyethylene (PE) composite foil with high-density polyethylene (HDPE) Flap cover, containing 80 Cellulose wipes;
Dispenser bag of PE composite foil, containing 70 Cellulose wipes used with dispenser box
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 wipes
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:
Scientific name: no data
Common name: Yeasts
Development stage:
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
Flow-pack of polyethylene (PE) composite foil with high-density polyethylene (HDPE) Flap cover, containing 80 Cellulose wipes;
Dispenser bag of PE composite foil, containing 70 Cellulose wipes used with dispenser box
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.
For wipes reseal the package after opening.
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) 2023/1073 of 1 June 2023 granting a Union authorisation for the single biocidal product ‘Spray On wipes’ 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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