COMMISSION IMPLEMENTING REGULATION (EU) 2022/2127
of 4 November 2022
granting a Union authorisation for the biocidal product family ‘Ecolab UA BPF 1-Propanol’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(Text with EEA relevance)
Article 1
Article 2
ANNEX
Summary of product characteristics for a biocidal product family
Ecolab UA BPF 1-Propanol
Product type 1 – Human hygiene (Disinfectants)
Authorisation number: EU-0028430-0000
R4BP asset number: EU-0028430-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1.
Family name
Name |
Ecolab UA BPF 1-Propanol |
1.2.
Product type(s)
Product type(s) |
PT01 – Human hygiene (Disinfectants) |
1.3.
Authorisation holder
Name and address of the authorisation holder |
Name |
Ecolab Deutschland GmbH |
Address |
Ecolab Allee 1, 40789 Monheim am Rhein Germany |
|
Authorisation number |
EU-0028430-0000 |
|
R4BP asset number |
EU-0028430-0000 |
|
Date of the authorisation |
27 November 2022 |
|
Expiry date of the authorisation |
31 October 2032 |
1.4.
Manufacturer(s) of the biocidal products
Name of manufacturer |
Ecolab Europe GmbH |
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Address of manufacturer |
Richtistrasse 7, 8304 Walliselen Switzerland |
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Location of manufacturing sites |
|
1.5.
Manufacturer(s) of the active substance(s)
Active substance |
Propan-1-ol |
Name of manufacturer |
BASF SE |
Address of manufacturer |
Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany |
Location of manufacturing sites |
Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany |
Active substance |
Propan-1-ol |
Name of manufacturer |
OQ Corporation |
Address of manufacturer |
2001 FM 3057, TX 77414 Bay City United States |
Location of manufacturing sites |
2001 FM 3057, TX 77414 Bay City United States |
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 |
70,35 |
75,38 |
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 |
70,35 |
75,38 |
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. Wear face protection. Wear eye protection. 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. Avoid breathing vapours. Call a POISONCENTRE/doctor if you feel unwell. |
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 |
Hygienic hand rub |
Target organism(s) (including development stage) |
Scientific name: Bacteria Common name: Bacteria Development stage: Scientific name: Tuberculosis bacilli Common name: Tuberculosis bacilli Development stage: Scientific name: Yeasts Common name: Yeasts Development stage: Scientific name: Enveloped viruses Common name: Enveloped viruses Development stage: Scientific name: Viruses (limited spectrum virucidal activity) Common name: Viruses (limited spectrum virucidal activity) Development stage: |
Field(s) of use |
Indoor Indoor Hand disinfection Food processing areas (industry, institutional and hospital kitchen areas (no contact with patients)) Hygienic hand rub, on visibly clean hands |
Application method(s) |
Method: Manual or automatic pump Detailed description: Manual (elbow lever or touchless) Automatic (by pump) |
Application rate(s) and frequency |
Application Rate: 3 ml Dilution (%): Ready to use Number and timing of application: 10 times per day |
Category(ies) of users |
Industrial Professional |
Pack sizes and packaging material |
100-20 000 l HEDP bottle, jerry can. |
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
5. GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1
5.1.
Instructions for use
Use 1 – Hand disinfection
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) |
Skinman Sensitive |
Market area: EU |
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|
P3-Manodes LI |
Market area: EU |
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Epicare DES |
Market area: EU |
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Manodes LI |
Market area: EU |
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Authorisation number |
EU-0028430-0001 1-1 |
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Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
70,35 |