COMMISSION IMPLEMENTING REGULATION (EU) 2022/1282
of 8 July 2022
granting a Union authorisation for the biocidal product family ‘Knieler & Team Propanol Family’
(Text with EEA relevance)
Article 1
Article 2
ANNEX
Summary of product characteristics for a biocidal product family
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1.
Family name
Name |
Knieler & Team Propanol Family |
1.2.
Product type(s)
Product type(s) |
PT01 - Human hygiene (Disinfectants) PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT04 - Food and feed area (Disinfectants) |
1.3.
Authorisation holder
Name and address of the authorisation holder |
Name |
Knieler & Team GmbH |
Address |
Kattrepelsbrücke 1, 20095 Hamburg Germany |
|
Authorisation number |
EU-0027467-0000 |
|
R4BP asset number |
EU-0027467-0000 |
|
Date of the authorisation |
11 August 2022 |
|
Expiry date of the authorisation |
31 July 2032 |
1.4.
Manufacturer(s) of the biocidal products
Name of manufacturer |
Knieler & Team GmbH |
Address of manufacturer |
Kattrepelsbrücke 1, 20095 Hamburg Germany |
Location of manufacturing sites |
Knieler & Team GmbH, Kattrepelsbrücke 1, 20095 Hamburg Germany A.F.P. Antiseptica Forschungs- und Produktionsgesellschaft mbH, Otto-Brenner-Straße 16-18, 21337 Lüneburg Germany |
1.5.
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 |
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 FAMILY COMPOSITION AND FORMULATION
2.1.
Qualitative and quantitative information on the composition of the family
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Min |
Max |
|||||
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
12,229 |
35,0 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
30,0 |
63,14 |
2.2.
Type(s) of formulation
Formulation(s) |
AL - Any other liquid |
PART II
SECOND INFORMATION LEVEL - META SPC(S)
META SPC 1
1. META SPC 1 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 1 identifier
Identifier |
meta SPC 1 |
1.2.
Suffix to the authorisation number
Number |
1-1 |
1.3.
Product type(s)
Product type(s) |
PT01 - Human hygiene (Disinfectants) |
2. META SPC 1 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 1
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Min |
Max |
|||||
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
30,0 |
32,5 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
45,0 |
45,0 |
2.2.
Type(s) of formulation of the meta SPC 1
Formulation(s) |
AL - Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
Hazard statements |
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) OF THE META SPC 1
4.1.
Use description
Product type |
PT01 - Human hygiene (Disinfectants) |
||||||
Where relevant, an exact description of the authorised use |
Not relevant |
||||||
Target organism(s) (including development stage) |
Scientific name: other Common name: Bacteria Development stage: Scientific name: other Common name: Mycobacteria Development stage: Scientific name: other Common name: Yeasts Development stage: Scientific name: other Common name: Enveloped viruses Development stage: |
||||||
Field(s) of use |
Indoor
|
||||||
Application method(s) |
Method: Manual application Detailed description: Rubbing |
||||||
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: There is no restriction in the number and timing of applications. No safety intervals need to be considered between the application phases. The product may be used at any time and as often as required. |
||||||
Category(ies) of users |
Industrial Professional |
||||||
Pack sizes and packaging material |
100, 125, 500, 1 000 ml in transparent/white high-density polyethylene (HDPE) bottles with polypropylene (PP) flip top caps; 5 000 ml transparent/white HDPE canister with HDPE screwed cap. In addition, exclusively for E-HDL (product 1.2): 500 and 1 000 ml in transparent HDPE lightweight bottle with integrated PP pump. |
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) |
Where relevant, an exact description of the authorised use |
Not relevant |
Target organism(s) (including development stage) |
Scientific name: other Common name: Bacteria Development stage: Scientific name: other Common name: Mycobacteria Development stage: Scientific name: other Common name: Yeasts Development stage: Scientific name: other Common name: enveloped viruses Development stage: |
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. |
Application method(s) |
Method: Manual application Detailed description: Rubbing |
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: There is no restriction in the number and timing of applications. No safety intervals need to be considered between the application phases. The product may be used at any time and as often as required. |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
100, 125, 500, 1 000 ml in transparent/white high-density polyethylene (HDPE) bottles with polypropylene (PP) flip top caps; 5 000 ml transparent/white HDPE canister with HDPE screwed cap. In addition, exclusively for E-HDL (product 1.2): 500 and 1 000 ml in transparent HDPE lightweight bottle with integrated PP pump. |
4.2.1.
Use-specific instructions for use
4.2.2.
Use-specific risk mitigation measures
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
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5. GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
A-HDL |
Market area: EU |
|||
Authorisation number |
EU-0027467-0001 1-1 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
32,5 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
45,0 |
7.2.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
E-HDL |
Market area: EU |
|||
Authorisation number |
EU-0027467-0002 1-1 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
30,0 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
45,0 |
7.3.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
H-HDL |
Market area: EU |
|||
Authorisation number |
EU-0027467-0003 1-1 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
30,0 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
45,0 |
META SPC 2
1. META SPC 2 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 2 identifier
Identifier |
meta SPC 2 |
1.2.
Suffix to the authorisation number
Number |
1-2 |
1.3.
Product type(s)
Product type(s) |
PT01 - Human hygiene (Disinfectants) |
2. META SPC 2 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 2
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Min |
Max |
|||||
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
20,0 |
20,0 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
60,0 |
60,0 |
2.2.
Type(s) of formulation of the meta SPC 2
Formulation(s) |
AL - Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
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) OF THE META SPC 2
4.1.
Use description
Product type |
PT01 - Human hygiene (Disinfectants) |
||||||
Where relevant, an exact description of the authorised use |
Not relevant |
||||||
Target organism(s) (including development stage) |
Scientific name: other Common name: Bacteria Development stage: Scientific name: other Common name: Tuberculosis bacilli Development stage: Scientific name: other Common name: Yeasts Development stage: Scientific name: other Common name: Enveloped viruses Development stage: |
||||||
Field(s) of use |
Indoor
|
||||||
Application method(s) |
Method: Manual application Detailed description: Rubbing |
||||||
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: There is no restriction in the number and timing of applications. No safety intervals need to be considered between the application phases. The product may be used at any time and as often as required. |
||||||
Category(ies) of users |
Industrial Professional |
||||||
Pack sizes and packaging material |
150, 500, 1 000 ml in transparent/white high-density polyethylene (HDPE) bottles with polypropylene (PP) flip top caps; 5 000 ml HDPE canister with transparent/white HDPE screwed cap; 700 and 1 000 ml vacuum bag in white PE composite foil with integrated PP pump/valve and PE 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) |
Where relevant, an exact description of the authorised use |
Not relevant |
Target organism(s) (including development stage) |
Scientific name: other Common name: Bacteria Development stage: Scientific name: other Common name: Tuberculosis bacilli Development stage: Scientific name: other Common name: Yeasts Development stage: Scientific name: other Common name: enveloped viruses Development stage: |
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. |
Application method(s) |
Method: Manual application Detailed description: Rubbing |
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: There is no restriction in the number and timing of applications. No safety intervals need to be considered between the application phases. The product may be used at any time and as often as required. |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
150, 500, 1 000 ml in transparent/white high-density polyethylene (HDPE) bottles with polypropylene (PP) flip top caps; 5 000 ml HDPE canister with transparent/white HDPE screwed cap; 700 and 1 000 ml vacuum bag in white PE composite foil with integrated PP pump/valve and PE cap. |
4.2.1.
Use-specific instructions for use
4.2.2.
Use-specific risk mitigation measures
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
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5. GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
C-HDL |
Market area: EU |
|||
Authorisation number |
EU-0027467-0004 1-2 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
20,0 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
60,0 |
META SPC 3
1. META SPC 3 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 3 identifier
Identifier |
meta SPC 3 |
1.2.
Suffix to the authorisation number
Number |
1-3 |
1.3.
Product type(s)
Product type(s) |
PT01 - Human hygiene (Disinfectants) |
2. META SPC 3 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 3
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Min |
Max |
|||||
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
12,229 |
14,3 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
62,751 |
63,14 |
2.2.
Type(s) of formulation of the meta SPC 3
Formulation(s) |
AL - Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
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) OF THE META SPC 3
4.1.
Use description
Product type |
PT01 - Human hygiene (Disinfectants) |
||||||
Where relevant, an exact description of the authorised use |
Not relevant |
||||||
Target organism(s) (including development stage) |
Scientific name: other Common name: Bacteria Development stage: Scientific name: other Common name: Tuberculosis bacilli Development stage: Scientific name: other Common name: Yeasts Development stage: Scientific name: other Common name: Enveloped viruses Development stage: |
||||||
Field(s) of use |
Indoor
|
||||||
Application method(s) |
Method: Manual application Detailed description: Rubbing |
||||||
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: There is no restriction in the number and timing of applications. No safety intervals need to be considered between the application phases. The product may be used at any time and as often as required. |
||||||
Category(ies) of users |
Industrial Professional |
||||||
Pack sizes and packaging material |
100, 125, 150, 500, 1 000 ml in transparent/white high-density polyethylene (HDPE) bottles with polyethylene (PP) flip top caps; 5 000 ml transparent/white HDPE canister with HDPE screwed cap. In addition, exclusively for D-HDL (product 3.1): 100, 125, 150, 500, 1 000 ml in white HDPE bottles with PP flip top caps; 5 000 ml white HDPE canister with HDPE screwed cap. In addition, exclusively for B-HDL (product 3.3): 700 ml Pouch of transparent PE composite foil with integrated PP pump; 75 ml transparent/white 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) |
Where relevant, an exact description of the authorised use |
Not relevant. |
Target organism(s) (including development stage) |
Scientific name: other Common name: Bacteria Development stage: Scientific name: other Common name: Tuberculosis bacilli Development stage: Scientific name: other Common name: Yeasts Development stage: Scientific name: other Common name: enveloped viruses Development stage: |
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. |
Application method(s) |
Method: Manual application Detailed description: Rubbing |
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: There is no restriction in the number and timing of applications. No safety intervals need to be considered between the application phases. The product may be used at any time and as often as required. |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
100, 125, 150, 500, 1 000 ml in transparent/white high-density polyethylene (HDPE) bottles with polyethylene (PP) flip top caps; 5 000 ml transparent/white HDPE canister with HDPE screwed cap. In addition, exclusively for D-HDL (product 3.1): 100, 125, 150, 500, 1 000 ml in white HDPE bottles with PP flip top caps; 5 000 ml white HDPE canister with HDPE screwed cap. In addition, exclusively for B-HDL (product 3.3): 700 ml Pouch of transparent PE composite foil with integrated PP pump; 75 ml transparent/white HDPE bottle with PP flip top cap. |
4.2.1.
Use-specific instructions for use
4.2.2.
Use-specific risk mitigation measures
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
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5. GENERAL DIRECTIONS FOR USE (3) OF THE META SPC 3
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
D-HDL |
Market area: EU |
|||
Authorisation number |
EU-0027467-0005 1-3 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
12,229 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
62,751 |
7.2.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
G-HDL |
Market area: EU |
|||
Authorisation number |
EU-0027467-0006 1-3 |
||||
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 |
7.3.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
B-HDL |
Market area: EU |
|||
Authorisation number |
EU-0027467-0007 1-3 |
||||
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 |
META SPC 4
1. META SPC 4 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 4 identifier
Identifier |
meta SPC 4 |
1.2.
Suffix to the authorisation number
Number |
1-4 |
1.3.
Product type(s)
Product type(s) |
PT01 - Human hygiene (Disinfectants) |
2. META SPC 4 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 4
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Min |
Max |
|||||
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
30,0 |
32,5 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
45,0 |
45,0 |
2.2.
Type(s) of formulation of the meta SPC 4
Formulation(s) |
AL - Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
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) OF THE META SPC 4
4.1.
Use description
Product type |
PT01 - Human hygiene (Disinfectants) |
||||||
Where relevant, an exact description of the authorised use |
Not relevant |
||||||
Target organism(s) (including development stage) |
Scientific name: other Common name: Bacteria Development stage: Scientific name: other Common name: Mycobacteria Development stage: Scientific name: other Common name: Yeasts Development stage: Scientific name: other Common name: Enveloped viruses Development stage: |
||||||
Field(s) of use |
Indoor
|
||||||
Application method(s) |
Method: Manual application Detailed description: Rubbing |
||||||
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: There is no restriction in the number and timing of applications. No safety intervals need to be considered between the application phases. The product may be used at any time and as often as required. |
||||||
Category(ies) of users |
Industrial Professional |
||||||
Pack sizes and packaging material |
100, 125, 500, 1 000 ml in transparent/white high-density polyethylene (HDPE) bottles with polypropylene (PP) flip top caps; 5 000 ml transparent/white HDPE canister with HDPE screwed cap. In addition, exclusively for E-HDG (product 4.2): 500 and 1 000 ml in transparent HDPE lightweight bottle with integrated PP pump. |
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) |
Where relevant, an exact description of the authorised use |
Not relevant |
Target organism(s) (including development stage) |
Scientific name: other Common name: Bacteria Development stage: Scientific name: other Common name: Mycobacteria Development stage: Scientific name: other Common name: Yeasts Development stage: Scientific name: other Common name: enveloped viruses Development stage: |
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. |
Application method(s) |
Method: Manual application Detailed description: Rubbing |
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: There is no restriction in the number and timing of applications. No safety intervals need to be considered between the application phases. The product may be used at any time and as often as required. |
Category(ies) of users |
Professional |
Pack sizes and packaging material |
100, 125, 500, 1 000 ml in transparent/white high-density polyethylene (HDPE) bottles with polypropylene (PP) flip top caps; 5 000 ml transparent/white HDPE canister with HDPE screwed cap. In addition, exclusively for E-HDG (product 4.2): 500 and 1 000 ml in transparent HDPE lightweight bottle with integrated PP pump. |
4.2.1.
Use-specific instructions for use
4.2.2.
Use-specific risk mitigation measures
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
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5. GENERAL DIRECTIONS FOR USE (4) OF THE META SPC 4
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
A-HDG |
Market area: EU |
|||
Authorisation number |
EU-0027467-0008 1-4 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
32,5 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
45,0 |
7.2.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
E-HDG |
Market area: EU |
|||
Authorisation number |
EU-0027467-0009 1-4 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
30,0 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
45,0 |
META SPC 5
1. META SPC 5 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 5 identifier
Identifier |
meta SPC 5 |
1.2.
Suffix to the authorisation number
Number |
1-5 |
1.3.
Product type(s)
Product type(s) |
PT01 - Human hygiene (Disinfectants) |
2. META SPC 5 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 5
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Min |
Max |
|||||
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
14,3 |
15,5 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
60,0 |
63,14 |
2.2.
Type(s) of formulation of the meta SPC 5
Formulation(s) |
AL - Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
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) OF THE META SPC 5
4.1.
Use description
Product type |
PT01 - Human hygiene (Disinfectants) |
||||||
Where relevant, an exact description of the authorised use |
Not relevant |
||||||
Target organism(s) (including development stage) |
Scientific name: other Common name: Bacteria Development stage: Scientific name: other Common name: Tuberculosis bacilli Development stage: Scientific name: other Common name: Yeasts Development stage: Scientific name: other Common name: Enveloped viruses Development stage: |
||||||
Field(s) of use |
Indoor
|
||||||
Application method(s) |
Method: Manual application Detailed description: Rubbing |
||||||
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: There is no restriction in the number and timing of applications. No safety intervals need to be considered between the application phases. The product may be used at any time and as often as required. |
||||||
Category(ies) of users |
Industrial Professional |
||||||
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. In addition, exclusively for C-HDG (product 5.1): 700 and 1 000 ml vacuum bag in white PE composite foil with integrated PP pump/valve and PE cap. In addition, exclusively for B-HDG (product 5.2): 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) |
Where relevant, an exact description of the authorised use |
Not relevant |
Target organism(s) (including development stage) |
Scientific name: other Common name: Bacteria Development stage: Scientific name: other Common name: Tuberculosis bacilli Development stage: Scientific name: other Common name: Yeasts Development stage: Scientific name: other Common name: enveloped viruses Development stage: |
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. |
Application method(s) |
Method: Manual application Detailed description: Rubbing |
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: There is no restriction in the number and timing of applications. No safety intervals need to be considered between the application phases. The product may be used at any time and as often as required. |
Category(ies) of users |
Professional |
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. In addition, exclusively for C-HDG (product 5.1): 700 and 1 000 ml vacuum bag in white PE composite foil with integrated PP pump/valve and PE cap. In addition, exclusively for B-HDG (product 5.2): 700 ml pouch of transparent PE composite foil with integrated PP pump; 75 ml transparent HDPE bottle with PP flip top cap. |
4.2.1.
Use-specific instructions for use
4.2.2.
Use-specific risk mitigation measures
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
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5. GENERAL DIRECTIONS FOR USE (5) OF THE META SPC 5
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
C-HDG |
Market area: EU |
|||
Authorisation number |
EU-0027467-0010 1-5 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
15,5 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
60,0 |
7.2.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
B-HDG |
Market area: EU |
|||
Authorisation number |
EU-0027467-0011 1-5 |
||||
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 |
META SPC 6
1. META SPC 6 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 6 identifier
Identifier |
meta SPC 6 |
1.2.
Suffix to the authorisation number
Number |
1-6 |
1.3.
Product type(s)
Product type(s) |
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT04 - Food and feed area (Disinfectants) |
2. META SPC 6 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 6
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Min |
Max |
|||||
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
25,0 |
35,0 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
30,0 |
40,0 |
2.2.
Type(s) of formulation of the meta SPC 6
Formulation(s) |
AL - Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6
Hazard statements |
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.. 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) OF THE META SPC 6
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: other Common name: Bacteria Development stage: Scientific name: other Common name: Yeasts Development stage: Scientific name: other Common name: viruses (limited spectrum virucidal activity) 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 surface disinfectant at room temperature (20±2 °C). The entire surface to be disinfected is wetted by pouring or spraying from a short distance and subsequently thoroughly wiped with a cloth. The amount of product should be sufficient (max. 50 ml/m2 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 • for the control of viruses (limited spectrum virucidal activity): 5 min 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 |
100, 500, 750 and 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
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: other Common name: Bacteria Development stage: Scientific name: other Common name: Yeasts Development stage: |
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 a short distance and subsequently thoroughly wiped with a cloth. The amount of product should be sufficient (max. 50 ml/m2) 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 |
100, 500, 750 and 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
4.2.2.
Use-specific risk mitigation measures
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
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5. GENERAL DIRECTIONS FOR USE (6) OF THE META SPC 6
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
F-FDL |
Market area: EU |
|||
Authorisation number |
EU-0027467-0012 1-6 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
25,0 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
30,0 |
7.2.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
A-FDL |
Market area: EU |
|||
Authorisation number |
EU-0027467-0013 1-6 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
35,0 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
35,0 |
7.3.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
C-FDL |
Market area: EU |
|||
Authorisation number |
EU-0027467-0014 1-6 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
30,0 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
40,0 |
7.4.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
E-FDL |
Market area: EU |
|||
Authorisation number |
EU-0027467-0015 1-6 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
25,0 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
40,0 |
META SPC 7
1. META SPC 7 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 7 identifier
Identifier |
meta SPC 7 |
1.2.
Suffix to the authorisation number
Number |
1-7 |
1.3.
Product type(s)
Product type(s) |
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT04 - Food and feed area (Disinfectants) |
2. META SPC 7 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 7
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Min |
Max |
|||||
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
14,3 |
14,925 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
44,73 |
63,14 |
2.2.
Type(s) of formulation of the meta SPC 7
Formulation(s) |
AL - Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7
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) OF THE META SPC 7
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: other Common name: Bacteria Development stage: Scientific name: other Common name: Yeasts Development stage: Scientific name: other Common name: Enveloped viruses Development stage: |
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/m2) 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
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: other Common name: Bacteria Development stage: Scientific name: other Common name: Yeasts Development stage: |
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/m2) 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
4.2.2.
Use-specific risk mitigation measures
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
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5. GENERAL DIRECTIONS FOR USE (7) OF THE META SPC 7
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
D-FDL |
Market area: EU |
|||
Authorisation number |
EU-0027467-0016 1-7 |
||||
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 |
7.2.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
B-FDL |
Market area: EU |
|||
Authorisation number |
EU-0027467-0017 1-7 |
||||
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 |
META SPC 8
1. META SPC 8 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 8 identifier
Identifier |
meta SPC 8 |
1.2.
Suffix to the authorisation number
Number |
1-8 |
1.3.
Product type(s)
Product type(s) |
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT04 - Food and feed area (Disinfectants) |
2. META SPC 8 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 8
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Min |
Max |
|||||
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
25,0 |
30,0 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
30,0 |
40,0 |
2.2.
Type(s) of formulation of the meta SPC 8
Formulation(s) |
AL - Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8
Hazard statements |
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 or doctor/physician. Store in a well-ventilated place. Keep cool. Store locked up. Dispose of container to an authorised waste collection point. |
4. AUTHORISED USE(S) OF THE META SPC 8
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: other Common name: Bacteria Development stage: Scientific name: other Common name: Yeasts Development stage: Scientific name: other Common name: viruses (limited spectrum virucidal activity) 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 • for the control of viruses (limited spectrum virucidal activity): 5 min; 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 white polyethylene (PE)-composite foil with polypropylene (PP) Flap cover, containing 40 30% Viscose and 70% Polyethylene Terephtalate (VIS/PET) wipes. Exclusively for C-FDT (product 8.2): Transparent high-density polyethylene (HDPE) Canister with PP screwed cap, containing 30 PET wipes; Dispenser bag of white PE composite foil, containing 30 or 90 PET wipes used with dispenser box. |
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: other Common name: Bacteria Development stage: Scientific name: other Common name: Yeasts Development stage: |
Field(s) of use |
Indoor Health care facilities and 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 disinfectant wipes at room temperature (20±2 °C). The surface to be disinfected is wiped and 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 white polyethylene (PE)-composite foil with polypropylene (PP) Flap cover, containing 40 30% viscose and 70% polyethylene terephtalate (VIS/PET) wipes. Exclusively for C-FDT (product 8.2): Transparent high-density polyethylene (HDPE) Canister with PP screwed cap, containing 30 PET wipes; Dispenser bag of white PE composite foil, containing 30 or 90 PET wipes used with dispenser box. |
4.2.1. Use-specific instructions for use
4.2.2.
Use-specific risk mitigation measures
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
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5. GENERAL DIRECTIONS FOR USE (8) OF THE META SPC 8
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
F-FDT |
Market area: EU |
|||
Authorisation number |
EU-0027467-0018 1-8 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
25,0 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
30,0 |
7.2.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
C-FDT |
Market area: EU |
|||
Authorisation number |
EU-0027467-0019 1-8 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
30,0 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
40,0 |
META SPC 9
1. META SPC 9 ADMINISTRATIVE INFORMATION
1.1.
Meta SPC 9 identifier
Identifier |
meta SPC 9 |
1.2.
Suffix to the authorisation number
Number |
1-9 |
1.3.
Product type(s)
Product type(s) |
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) PT04 - Food and feed area (Disinfectants) |
2. META SPC 9 COMPOSITION
2.1.
Qualitative and quantitative information on the composition of the meta SPC 9
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Min |
Max |
|||||
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
14,3 |
14,925 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
44,73 |
63,14 |
2.2.
Type(s) of formulation of the meta SPC 9
Formulation(s) |
AL - Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9
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) OF THE META SPC 9
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: other Common name: Bacteria Development stage: Scientific name: other Common name: Yeasts Development stage: Scientific name: other 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 Exclusively for B-FDT (product 9.2): 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: other Common name: Bacteria Development stage: Scientific name: other 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 Exclusively for B-FDT (product 9.2): Dispenser of PE composite foil with screwed-in PE cap, containing 100 PP/PE wipes. |
4.2.1.
Use-specific instructions for use
4.2.2.
Use-specific risk mitigation measures
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
4.2.4.
Where specific to the use, the instructions for safe disposal of the product and its packaging
4.2.5.
Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
5. GENERAL DIRECTIONS FOR USE (9) OF THE META SPC 9
5.1.
Instructions for use
5.2.
Risk mitigation measures
5.3.
Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
5.4.
Instructions for safe disposal of the product and its packaging
5.5.
Conditions of storage and shelf-life of the product under normal conditions of storage
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 9
7.1.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
D-FDT |
Market area: EU |
|||
Authorisation number |
EU-0027467-0020 1-9 |
||||
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 |
7.2.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
B-FDT |
Market area: EU |
|||
Authorisation number |
EU-0027467-0021 1-9 |
||||
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 |