COMMISSION IMPLEMENTING REGULATION (EU) 2022/1186
of 8 July 2022
granting a Union authorisation for the biocidal product family ‘L+R Propanol PT1 Family’
(Text with EEA relevance)
Article 1
Article 2
ANNEX
Summary of product characteristics for a biocidal product family
L+R Propanol PT1 Family
Product type 1 - Human hygiene (Disinfectants)
Authorisation number: EU-0027466-0000
R4BP asset number: EU-0027466-0000
PART I
FIRST INFORMATION LEVEL
1.
ADMINISTRATIVE INFORMATION
1.1.
Family name
Name |
L+R Propanol PT1 Family |
1.2.
Product type(s)
Product type(s) |
PT01 - Human hygiene (Disinfectants) |
1.3.
Authorisation holder
Name and address of the authorisation holder |
Name |
Lohmann & Rauscher International GmbH & Co. KG |
Address |
Westerwaldstrasse 4, 56579 Rengsdorf Germany |
|
Authorisation number |
EU-0027466-0000 |
|
R4BP asset number |
EU-0027466-0000 |
|
Date of the authorisation |
31 July 2022 |
|
Expiry date of the authorisation |
30 June 2032 |
1.4.
Manufacturer(s) of the biocidal products
Name of manufacturer |
Lohmann & Rauscher International GmbH & Co. KG |
Address of manufacturer |
Westerwaldstrasse 4, 56579 Rengsdorf Germany |
Location of manufacturing sites |
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-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 |
Active substance |
Propan-1-ol |
Name of manufacturer |
OQ Chemicals GmbH (formerly OXEA) |
Address of manufacturer |
Rheinpromenade 4a, 40789 Monheim am Rhein Germany |
Location of manufacturing sites |
OQ Chemicals Corporation, 2001 FM 3057 (formerly OXEA Corporation), TX 77414-2968 Bay City United States |
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-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 |
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-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
45,0 |
45,0 |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
30,0 |
30,0 |
Tetradecanol |
Myristil alcohol |
Non-active substance |
112-72-1 |
204-000-3 |
0,0 |
0,95 |
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-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
45,0 |
45,0 |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
30,0 |
30,0 |
Tetradecanol |
Myristil alcohol |
Non-active substance |
112-72-1 |
204-000-3 |
0,95 |
0,95 |
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. Harmful to aquatic life with long lasting effects. 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. Avoid release to the environment. 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 approved waste disposal plant. |
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: Yeasts Development stage: Scientific name: other Common name: Mycobacteria Development stage: Scientific name: other Common name: viruses (limited spectrum of virucidal activity) 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). Minimum contact time: 30 sec 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 |
100ml, 500ml and 1000ml in transparent HDPE bottles 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: Yeasts Development stage: Scientific name: other Common name: Mycobacteria Development stage: Scientific name: other Common name: viruses (limited spectrum of virucidal activity) 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: in portions of 3 ml (use dispensers: for example set to 1.5 ml per stroke, 2 strokes per 3 ml). Minimum exposure time: 90s 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 |
100ml, 500ml and 1 000 ml in transparent HDPE bottles 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
(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) |
L+R handdisinfect blue |
Market area: EU |
|||
Authorisation number |
EU-0027466-0001 1-1 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
45,0 |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
30,0 |
Tetradecanol |
Myristil alcohol |
Non-active substance |
112-72-1 |
204-000-3 |
0,95 |
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-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
45,0 |
45,0 |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
30,0 |
30,0 |
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 |
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 approved waste disposal plant. |
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: Yeasts Development stage: Scientific name: other Common name: Mycobacteria Development stage: Scientific name: other Common name: viruses (limited spectrum of virucidal activity) 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). Minimum exposure time: 30s 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 |
100ml, 500ml and 1 000 ml in transparent HDPE bottles 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: Yeasts Development stage: Scientific name: other Common name: Mycobacteria Development stage: Scientific name: other Common name: viruses (limited spectrum of virucidal activity) 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: in portions of 3 ml (use dispensers: for example set to 1.5 ml per stroke, 2 strokes per 3 ml). Minimum exposure time: 90s 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 |
100ml, 500ml and 1 000 ml in transparent HDPE bottles 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
(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) |
L+R handdisinfect 03 |
Market area: EU |
|||
Authorisation number |
EU-0027466-0002 1-2 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
45,0 |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
30,0 |
7.2.
Trade name(s), authorisation number and specific composition of each individual product
Trade name(s) |
L+R handdisinfect 04 |
Market area: EU |
|||
Authorisation number |
EU-0027466-0003 1-2 |
||||
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
45,0 |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
30,0 |