Commission Implementing Regulation (EU) 2019/2029 of 29 November 2019 granting a Union authorisation for the single biocidal product CVAS Disinfectant product based on Propan-2-ol (Text with EEA relevance)

ANNEX
ANNEX
Summary of product characteristics for a biocidal product
CVAS Disinfectant product based on Propan-2-ol
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-0020461-0000
R4BP asset number: EU-0020461-0000
1.   ADMINISTRATIVE INFORMATION
1.1.    Trade name(s) of the product
Trade name(s)
CVAS Disinfectant product based on Propan-2-ol
calgonit DS 622
R 3000 SCHNELLDESINFEKTION
IPADES 70
Alpha Septin
Blu-Sept
Disinfect home
Schnell Des
Disinfect Rapid
Bakt-Ex Pur
Bakt-Ex Rapid
ROTIE-DES quick
Bactazol I
Dezynfektator
EOSSAN-Desinfektionsspray-Fluid
FS-7-Spray
Gartengeräte Hygiene Spray
NeudoClean Hygiene Spray
1.2.    Authorisation holder
Name and address of the authorisation holder
Name
CVAS Development GmbH
Address
Dr Albert Reimann Str. 16a, 68526, Ladenburg, Germany
Authorisation number
EU-0020461-0000
R4BP asset number
EU-0020461-0000
Date of the authorisation
24 December 2019
Expiry date of the authorisation
30 November 2029
1.3.    Manufacturer(s) of the product
Name of manufacturer
Brenntag GmbH
Address of manufacturer
Messeallee 11, 45131 Essen, Germany
Location of manufacturing sites
Am Nordseekai 22, 73207 Plochingen Germany
Name of manufacturer
Calvatis GmbH
Address of manufacturer
Dr Albert Reimann Str. 16a, 68526 Ladenburg Germany
Location of manufacturing sites
Dr Albert Reimann Str. 16a, 68526 Ladenburg Germany
Name of manufacturer
Arthur Schopf Hygiene GmbH & Co. KG
Address of manufacturer
Pfaffensteinstr. 1, 83115 Neubeuern Germany
Location of manufacturing sites
Pfaffensteinstr. 1, 83115 Neubeuern Germany
1.4.    Manufacturer(s) of the active substance(s)
Active substance
Propan-2-ol
Name of manufacturer
Shell Nederland Raffinaderij B.V.
Address of manufacturer
Vondelingenweg 601, 3196 KK, Vodelingenenplaat Rotterdam Netherlands
Location of manufacturing sites
Vondelingenweg 601, 3196 KK, Vodelingenenplaat Rotterdam Netherlands
Active substance
Propan-2-ol
Name of manufacturer
ExxonMobil
Address of manufacturer
4999 Scenic Highway, LA 70897 Baton Rouge, Louisana United States
Location of manufacturing sites
4999 Scenic Highway, LA 70897 Baton Rouge, Louisana United States
Active substance
Propan-2-ol
Name of manufacturer
INEOS Solvents Germany GmbH
Address of manufacturer
Römerstraße 733, 47443 Moers Germany
Location of manufacturing sites
Römerstraße 733, 47443 Moers 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-2-ol
Active Substance
67-63-0
200-661-7
61,25
2.2.    Type of formulation
Any other liquid (ready-to-use)
3.   HAZARD AND PRECAUTIONARY STATEMENTS
Hazard statements
Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements
If medical advice is needed, have product container or label at hand.
Keep out of reach of children.
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.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Call a POISON CENTER if you feel unwell.
If eye irritation persists: Get medical advice.
Store in a well-ventilated place. Keep cool.
Store locked up.
Dispose of contents/container in accordance with local regulations.
Wash hands thoroughly after handling.
IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
In case of fire: Use alcohol-resistant foam to extinguish.
4.   AUTHORISED USE(S)
4.1.    Use description
Table 1
Use # 1 — Disinfection of small surfaces by non-professional users (product-type 2)
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
-
Target organism(s) (including development stage)
Bacteria
Yeasts
Field(s) of use
Indoor
Disinfection of non-porous surfaces in domestic areas.
Application method(s)
Spraying
Spraying with trigger sprayer or pump spray
Spraying and wiping
Spraying with trigger sprayer or pump spray and wiping
Pouring and wiping
Application rate(s) and frequency
40-50 mL/m 2
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
1.
Bottle: High-density polyethylene (HDPE), 250 - 1 000 mL
2.
Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1 000 mL
4.1.1.    Use-specific instructions for use
The authorisation holder has to specify the typical application rate in a simple, easily understandable form on the label:
•
Trigger spray: Apply 20 spray strokes per 0,5 m 2 .
•
Pump spray: Apply 3 jets per 100 cm 2 .
•
Bottle: Apply one measuring cup per m 2 .
4.1.2.    Use-specific risk mitigation measures
See section 5.2.
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 section 5.3.
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See section 5.4.
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See section 5.5.
4.2.    Use description
Table 2
Use # 2 — Disinfection of small surfaces by professional users (product-type 2)
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
-
Target organism(s) (including development stage)
Bacteria
Yeasts
Field(s) of use
Indoor
Disinfection of non-porous surfaces in industry, small enterprises, institutions and domestic areas.
Application method(s)
Spraying
Spraying with trigger sprayer or pump spray
Spraying and wiping
Spraying with trigger sprayer or pump spray and wiping
Pouring and wiping
Application rate(s) and frequency
40-50 mL/m 2
Category(ies) of users
Professional
Pack sizes and packaging material
1.
Bottle: HDPE, 250 - 1 000 mL
2.
Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1 000 mL
3.
Intermediate bulk containers (IBC): HDPE, 720 L
4.
Drum: Steel, zinc coated and painted, 200 - 220 L
5.
Canister: HDPE, 5 - 50 L
4.2.1.    Use-specific instructions for use
See section 5.1.
4.2.2.    Use-specific risk mitigation measures
1.
The following personal risk mitigation measure can be considered for disinfection of food processing machinery and refilling procedure unless it can be replaced by technical and/or organisational measures: The use of eye protection during handling of the product is recommended.
2.
The product must only be applied for disinfection of small surfaces.
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 section 5.3.
4.2.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See section 5.4.
4.2.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See section 5.5.
4.3.    Use description
Table 3
Use # 3 — Disinfection of small surfaces by non-professional users (product-type 4)
Product type
PT04 — Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Bacteria
Yeasts
Field(s) of use
Indoor
Disinfection of non-porous surfaces in kitchens.
Disinfection of gardening equipment for human hygiene purpose only.
Application method(s)
Spraying
Spraying with trigger sprayer or pump spray
Spraying and wiping
Spraying with trigger sprayer or pump spray and wiping
Pouring and wiping
Application rate(s) and frequency
40-50 mL/m 2
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
1.
Bottle: HDPE, 250 - 1 000 mL
2.
Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1 000 mL
4.3.1.    Use-specific instructions for use
1.
For use at room temperature (20 ± 2 °C).
2.
The authorisation holder has to specify the typical application rate in a simple, easily understandable form on the label:
•
Trigger spray: Apply 20 spray strokes per 0,5 m 2 .
•
Pump spray: Apply 3 jets per 100 cm 2 .
•
Bottle: Apply one measuring cup per m 2
3.
Disinfection of gardening equipment for human hygiene purpose only.
4.
Disinfect gardening equipment only indoors.
4.3.2.    Use-specific risk mitigation measures
See section 5.2.
4.3.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See section 5.3.
4.3.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See section 5.4.
4.3.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See section 5.5.
4.4.    Use description
Table 4
Use # 4 — Disinfection of small surfaces by professional users (product-type 4)
Product type
PT04 — Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
-
Target organism(s) (including development stage)
Bacteria
Yeasts
Field(s) of use
Indoor
Disinfection of non-porous surfaces in canteens or kitchens, food processing industry (including breweries).
Disinfection of gardening equipment for human hygiene purpose only.
Application method(s)
Spraying
Spraying with trigger sprayer or pump spray
Spraying and wiping
Spraying with trigger sprayer or pump spray and wiping
Pouring and wiping
Application rate(s) and frequency
40-50 mL/m 2
Category(ies) of users
Professional
Pack sizes and packaging material
1.
Bottle: HDPE, 250 - 1 000 mL
2.
Bottle with fine mist spray pump or trigger spray head: HDPE, 250 - 1 000 mL
3.
IBC: HDPE, 720 L
4.
Drum: Steel, zinc coated and painted, 200 - 220 L
5.
Canister: HDPE, 5 - 50 L
4.4.1.    Use-specific instructions for use
1.
For use at room temperature (20 ± 2 °C).
2.
Disinfection of gardening equipment for human hygiene purpose only.
3.
Disinfect gardening equipment only indoors.
4.4.2.    Use-specific risk mitigation measures
1.
Provide adequate ventilation (industrial ventilation or keeping windows and doors open).
2.
The product must only be applied for disinfection of small surfaces.
3.
The following personal risk mitigation measure can be considered for disinfection of food processing machinery and refilling procedure unless it can be replaced by technical and/or organisational measures: The use of eye protection during handling of the product is recommended.
4.4.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See section 5.3.
4.4.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See section 5.4.
4.4.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See section 5.5.
5.   GENERAL DIRECTIONS FOR USE  ( 1 )
5.1.    Instructions for use
1.
Clean surfaces before use.
2.
Apply the product to the surface undiluted by spraying. Make sure to wet surfaces completely. Allow to take effect for at least 15 minutes.
3.
Apply the product to the surface undiluted by spraying/pouring the product and wiping of the surface afterwards. Make sure to wet surfaces completely. Allow to take effect for at least 5 minutes.
4.
Do not apply more than 50 mL/m 2 .
5.
Used wipes must be disposed in a closed container.
6.
For non-professional users only: Do not use more than 4 applications per day.
5.2.    Risk mitigation measures
1.
Keep out of reach of children and pets.
2.
Avoid contact with eyes.
3.
Do not apply in the presence of small children.
4.
Keep children and pets away from rooms, where disinfection is taking place. Provide adequate ventilation before children enter treated rooms.
5.
For refilling a funnel must be applied.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid:
1.
IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
2.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do – continue rinsing.
3.
Call a POISON CENTER or doctor/physician if you feel unwell.
4.
If eye irritation persists, get medical advice.
5.4.    Instructions for safe disposal of the product and its packaging
At the end of the treatment, dispose unused product and the packaging in accordance with local requirements.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
Store cool (not above 30 °C) and protect from frost.
Shelf-life: 24 months.
6.   OTHER INFORMATION
Please be aware of the European reference value of 129,28 mg/m 3 for the active substance propan-2-ol (CAS No.: 67-63-0) which was used for the risk assessment for the product.
( 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) 2019/2029 of 29 November 2019 granting a Union authorisation for the single biocidal product CVAS Disinfectant product based on Propan-2-ol (Text with EEA relevance)

Schedules & Appendices

Cite this act
