COMMISSION IMPLEMENTING REGULATION (EU) 2023/1108
of 6 June 2023
granting a Union authorisation for the single biocidal product ‘OP Plus’ 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
1.
ADMINISTRATIVE INFORMATION
1.1.
Trade name(s) of the product
Trade name(s) |
OP Plus Nextsept MyClean HB plus MyClean HB basic Bavicid Hand |
1.2.
Authorisation holder
Name and address of the authorisation holder |
Name |
Laboratorium Dr. Deppe GmbH |
Address |
Hooghe Weg 35, 47906 Kempen Germany |
|
Authorisation number |
EU-0027670-0000 |
|
R4BP asset number |
EU-0027670-0000 |
|
Date of the authorisation |
27 June 2023 |
|
Expiry date of the authorisation |
31 July 2032 |
1.3.
Manufacturer(s) of the product
Name of manufacturer |
Laboratorium Dr. Deppe GmbH |
Address of manufacturer |
Hooghe Weg 35, 47906 Kempen Germany |
Location of manufacturing sites |
Laboratorium Dr. Deppe GmbH, Hooghe Weg 35, 47906 Kempen Germany |
1.4.
Manufacturer(s) of the active substance(s)
Active substance |
Propan-1-ol |
Name of manufacturer |
OQ Chemicals GmbH (formerly Oxea GmbH) |
Address of manufacturer |
Rheinpromenade 4a, 40789 Monheim am Rhein Germany |
Location of manufacturing sites |
OQ Chemicals Corperation (formerly Oxea Coperation), 2001 FM 3057 TX, 77414 Bay City United States |
Active substance |
Propan-1-ol |
Name of manufacturer |
BASF SE |
Address of manufacturer |
Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany |
Location of manufacturing sites |
BASF SE, Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany |
Active substance |
Propan-1-ol |
Name of manufacturer |
SASOL Chemie GmbH & Co. KG |
Address of manufacturer |
Secunda Chemical Operations, Sasol Place, 50 Katherine Street, 2090 Sandton South Africa |
Location of manufacturing sites |
Secunda Chemical Operations, PDP Kruger Street, 2302 Secunda South Africa |
Active substance |
Propan-2-ol |
Name of manufacturer |
Stockmeier Chemie GmbH & Co. KG |
Address of manufacturer |
Am Stadtholz 37, 33609 Bielefeld Germany |
Location of manufacturing sites |
INEOS Solvent Germany GmbH, Römerstrasse 733, 47443 Moers Germany |
Active substance |
Propan-2-ol |
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Name of manufacturer |
Brenntag GmbH |
||
Address of manufacturer |
Stinnes-Platz 1, 45472 Mülheim an der Ruhr Germany |
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Location of manufacturing sites |
|
2.
PRODUCT COMPOSITION AND FORMULATION
2.1.
Qualitative and quantitative information on the composition of the product
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
Propan-1-ol |
|
Active Substance |
71-23-8 |
200-746-9 |
12,229 |
Propan-2-ol |
|
Active Substance |
67-63-0 |
200-661-7 |
62,751 |
2.2.
Type of formulation
3.
HAZARD AND PRECAUTIONARY STATEMENTS
Hazard statements |
Highly flammable liquid and vapour. Causes serious eye damage. May cause drowsiness or dizziness. Repeated exposure may cause skin dryness or cracking. |
Precautionary statements |
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking. Keep container tightly closed. Avoid breathing vapours. Use only outdoors or in a well-ventilated area. IF INHALED:Remove person to fresh air and keep comfortable for breathing. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/doctor. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of container to an authorised waste collection point. |
4.
AUTHORISED USE(S)
4.1.
Use description
Product type |
PT01 - Human hygiene (Disinfectants) |
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Where relevant, an exact description of the authorised use |
Not relevant |
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Target organism(s) (including development stage) |
Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Tuberculosis bacilli Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: Enveloped viruses Development stage: no data |
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Field(s) of use |
Indoor
|
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Application method(s) |
Method: Manual application Detailed description: Rubbing |
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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. |
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Category(ies) of users |
Industrial Professional |
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Pack sizes and packaging material |
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. |
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: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Tuberculosis bacilli Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: enveloped viruses Development stage: no data |
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 white HDPE bottles with PP flip top caps; 5 000 ml white HDPE canister with HDPE screwed cap. |