LegalizeCommission 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
A Union authorisation with authorisation number EU-0027466-0000 is granted to Lohmann & Rauscher International GmbH&Co.KG for the making available on the market and use of the biocidal product family ‘L+R Propanol PT1 Family’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 31 July 2022 until 30 June 2032.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX
Propanol PT1 Family
Product type(s)
PT01: Human hygiene
Authorisation number: EU-0027466-00
R4BP asset number: EU-0027466-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
| Name | Propanol PT1 Family |
|---|---|
| Product type(s) | PT01: Human hygiene |
| --- | --- |
| Name and address of the authorisation holder | Name |
| --- | --- |
| Address | Robert-Koch-Str. 2 22851 Norderstedt Germany |
| Authorisation number | |
| R4BP asset number | |
| Date of the authorisation | |
| Expiry date of the authorisation | |
| Name of manufacturer | Schülke & Mayr GmbH |
| --- | --- |
| Address of manufacturer | Robert-Koch-Str. 2 22851 Norderstedt Germany |
| Location of manufacturing sites | Schülke & Mayr GmbH site 1 Robert-Koch-Str. 2 22851 Norderstedt Germany |
| Name of manufacturer | A.F.P. Antiseptica Forschungs- und Produktionsgesellschaft mbH |
| --- | --- |
| Address of manufacturer | Otto-Brenner-Straße 16 21337 Lüneburg Germany |
| Location of manufacturing sites | A.F.P. Antiseptica Forschungs- und Produktionsgesellschaft mbH site 1 Otto-Brenner-Straße 16 21337 Lüneburg Germany |
| 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 site 1 INEOS Solvent Germany GmbH, Römerstrasse 733 47443 Moers Germany |
| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | Ineos Solvents Germany GmbH (formerly Sasol) |
| Address of manufacturer | Römerstraße 733 47443 Moers Germany |
| Location of manufacturing sites | Ineos Solvents Germany GmbH (formerly Sasol) site 2 Shamrockstr. 88 44623 Herne Germany |
| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | Shell Chemicals Europe B.V. |
| Address of manufacturer | Postbus 2334 3000 CH Rotterdam Netherlands (the) |
| Location of manufacturing sites | Shell Chemicals Europe B.V. site 1 BV/Shell Nederland Raffinaderij B.V. Vondelingenweg 601 3196 KK Rotterdam-Pernis Netherlands (the) |
| 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 GmbH (formerly OXEA) site 1 OQ Chemicals Corporation, 2001 FM 3057 (formerly OXEA Corporation) TX 77414-2968 Bay City United States (the) |
| 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 | Sasol Chemie GmbH & Co. KG site 1 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 site 1 BASF SE, Carl-Bosch-Str. 38 67056 Ludwigshafen Germany |
2. PRODUCT FAMILY COMPOSITION AND FORMULATION
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| Propan-2-ol | Active substance | 67-63-0 | 200-661-7 | 45 - 45 % (w/w) | |
| Propan-1-ol | Active substance | 71-23-8 | 200-746-9 | 30 - 30 % (w/w) | |
| Tetradecanol | Myristil alcohol | Non-active substance | 112-72-1 | 204-000-3 | 0 - 0,95 % (w/w) |
| Formulation type(s) | AL Any other liquid | ||||
| --- | --- |
PART II
SECOND INFORMATION LEVEL META SPC(S)
1. META SPC 1 ADMINISTRATIVE INFORMATION
| Identifier | Meta SPC: meta SPC 1 |
|---|---|
| Number | 1-1 |
| --- | --- |
| Product type(s) | PT01: Human hygiene |
| --- | --- |
2. META SPC 1 COMPOSITION
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| Propan-2-ol | Active substance | 67-63-0 | 200-661-7 | 45 - 45 % (w/w) | |
| Propan-1-ol | Active substance | 71-23-8 | 200-746-9 | 30 - 30 % (w/w) | |
| Tetradecanol | Myristil alcohol | Non-active substance | 112-72-1 | 204-000-3 | 0,95 - 0,95 % (w/w) |
| Formulation type(s) | AL Any other liquid | ||||
| --- | --- |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
| Hazard statements | H226: Flammable liquid and vapour. H318: Causes serious eye damage. H412: Harmful to aquatic life with long lasting effects. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. |
|---|---|
| Precautionary statements | P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P261: Avoid breathing vapours. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER / doctor. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of container to an approved waste disposal plant. |
4. AUTHORISED USE(S) OF THE META SPC
| Product type | PT01: Human hygiene |
|---|---|
| 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: no data Scientific name: other Common name: Yeasts Development stage: no data Scientific name: other Common name: Mycobacteria Development stage: no data Scientific name: other Common name: viruses (limited spectrum of virucidal activity) Development stage: no data |
| Field(s) of use | indoor use — hospitals and other health care institutions, ambulances, surgeries, nursing homes (including home-care of patients), — hospital canteens, large kitchens, pharmaceutical industries, production sites, laboratories: hygienic handrub onto visibly clean and dry hands. — for professional use only. |
| 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 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 ml, 500 ml and 1 000 ml in transparent HDPE bottles with PP flip top cap. |
The products can be applied directly, or the products can be used in a dispenser or with a pump.
For hygienic handrub use 3 ml of product and keep hands wet for 30 seconds.
See general directions for use of meta SPC 1
See general directions for use of meta SPC 1
See general directions for use of meta SPC 1
See general directions for use of meta SPC 1
| Product type | PT01: Human hygiene |
|---|---|
| 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: no data Scientific name: other Common name: Yeasts Development stage: no data Scientific name: other Common name: Mycobacteria Development stage: no data Scientific name: other Common name: viruses (limited spectrum of virucidal activity) Development stage: no data |
| Field(s) of use | indoor use 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 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 ml, 500 ml and 1 000 ml in transparent HDPE bottles with PP flip top cap. |
The products can be applied directly or the products can be used in a dispenser or with a pump.
For surgical handrub use as many portions of 3 ml as necessary to keep hands wet for 90 seconds.
See general directions for use of meta SPC 1
See general directions for use of meta SPC 1
See general directions for use of meta SPC 1
See general directions for use of meta SPC 1
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1
For professional use only.
Avoid contact with eyes.
Keep out of reach of children.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water. for 15 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Information to healthcare personnel/doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
After spilling: Take up with absorbent material (for example sand, kieselgur, universal binder). When picked up, treat material as prescribed under ‘Disposal considerations’.
Residuals must be removed from packaging and when emptied completely disposed of in accordance with the regulations for waste removal.
Incompletely emptied packaging must be disposed of in the form of disposal specified by the regional disposer.
Technical measures and storage conditions:
Shelf-life: 36 months
Keep container tightly closed and dry in a cool, well-ventilated place. Protect from direct sunlight.
Recommended storage temperature: 0-30°C
Requirements for storage rooms and vessels:
Containers which are opened must be carefully closed and kept upright to prevent leakage. Always keep in containers of same material as the original one.
Advice on storage assembly:
Do not store together with: oxidizing substances; spontaneously combusting substances.
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
| Trade name(s) | desmanol protect | Market area: EU | |||
|---|---|---|---|---|---|
| desmanol plus | Market area: EU | ||||
| desmanol pro | Market area: EU | ||||
| desmanol ultra | Market area: EU | ||||
| desmanol clinpure | Market area: EU | ||||
| desmanol advanced | Market area: EU | ||||
| desmanol ethanolfree | Market area: EU | ||||
| desmanol pro pure | Market area: EU | ||||
| sensiva protect | Market area: EU | ||||
| virusept protect | Market area: EU | ||||
| septoderm | Market area: EU | ||||
| microshield | Market area: EU | ||||
| Halasept 710 | 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 % (w/w) | |
| Propan-1-ol | Active substance | 71-23-8 | 200-746-9 | 30 % (w/w) | |
| Tetradecanol | Myristil alcohol | Non-active substance | 112-72-1 | 204-000-3 | 0,95 % (w/w) |
1. META SPC 2 ADMINISTRATIVE INFORMATION
| Identifier | Meta SPC: meta SPC 2 |
|---|---|
| Number | 1-2 |
| --- | --- |
| Product type(s) | PT01: Human hygiene |
| --- | --- |
2. META SPC 2 COMPOSITION
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| Propan-2-ol | Active substance | 67-63-0 | 200-661-7 | 45 - 45 % (w/w) | |
| Propan-1-ol | Active substance | 71-23-8 | 200-746-9 | 30 - 30 % (w/w) | |
| Formulation type(s) | AL Any other liquid | ||||
| --- | --- |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
| Hazard statements | H226: Flammable liquid and vapour. H318: Causes serious eye damage. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. |
|---|---|
| Precautionary statements | P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P261: Avoid breathing vapours. P271: Use only outdoors or in a well-ventilated area. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER/doctor. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of container to an approved waste disposal plant. |
4. AUTHORISED USE(S) OF THE META SPC
| Product type | PT01: Human hygiene |
|---|---|
| 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: no data Scientific name: other Common name: Yeasts Development stage: no data Scientific name: other Common name: Mycobacteria Development stage: no data Scientific name: other Common name: viruses (limited spectrum of virucidal activity) Development stage: no data |
| Field(s) of use | indoor use — hospitals and other health care institutions, ambulances, surgeries, nursing homes (including home-care of patients), — hospital canteens, large kitchens, pharmaceutical industries, production sites, laboratories: hygienic handrub onto visibly clean and dry hands. — for professional use only. |
| 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 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 ml, 500 ml and 1 000 ml in transparent HDPE bottles with PP flip top cap. |
The products can be applied directly or the products can be used with a dispenser or with a pump.
For hygienic handrub use 3 ml of product and keep hands wet for 30 seconds.
See general directions for use of meta SPC 2
See general directions for use of meta SPC 2
See general directions for use of meta SPC 2
See general directions for use of meta SPC 2
| Product type | PT01: Human hygiene |
|---|---|
| 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: no data Scientific name: other Common name: Yeasts Development stage: no data Scientific name: other Common name: Mycobacteria Development stage: no data Scientific name: other Common name: viruses (limited spectrum of virucidal activity) Development stage: no data |
| Field(s) of use | indoor use 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 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 ml, 500 ml and 1 000 ml in transparent HDPE bottles with PP flip top cap. |
The products can be applied directly or the products can be used with a dispenser or with a pump.
For surgical handrub use as many portions of 3 ml as necessary to keep hands wet for 90 seconds.
See general directions for use of meta SPC 2.
See general directions for use of meta SPC 2.
See general directions for use of meta SPC 2.
See general directions for use of meta SPC 2.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2
For professional use only
Avoid contact with eyes.
Keep out of reach of children.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water. for 15 minutes. Call a POISON CENTRE or a doctor.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
Information to healthcare personnel/doctor:
The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.
After spilling: Take up with absorbent material (for example sand, kieselgur, universal binder). When picked up, treat material as prescribed under ‘Disposal considerations’.
Residuals must be removed from packaging and when emptied completely disposed of in accordance with the regulations for waste removal.
Incompletely emptied packaging must be disposed of in the form of disposal specified by the regional disposer.
Technical measures and storage conditions:
Shelf-life: 36 months
Keep container tightly closed and dry in a cool, well-ventilated place. Protect from direct sunlight.
Recommended storage temperature: 0-30°C
Requirements for storage rooms and vessels:
Containers which are opened must be carefully closed and kept upright to prevent
leakage. Always keep in containers of same material as the original one.
Advice on storage assembly:
Do not store together with: oxidizing substances; spontaneously combusting substances
6. OTHER INFORMATION
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
| Trade name(s) | desmanol pure protect | Market area: EU | |||
|---|---|---|---|---|---|
| desmanol pure+ | Market area: EU | ||||
| desmanol pure pro | Market area: EU | ||||
| desmanol pure guard | Market area: EU | ||||
| desmanol expert | Market area: EU | ||||
| desmanol pure ultra | Market area: EU | ||||
| desmanol EF | Market area: EU | ||||
| desmanol clear | Market area: EU | ||||
| sensiva pure | Market area: EU | ||||
| virusept pure | Market area: EU | ||||
| septoderm pure | Market area: EU | ||||
| microshield pure | Market area: EU | ||||
| Halasept 720 | 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 % (w/w) | |
| Propan-1-ol | Active substance | 71-23-8 | 200-746-9 | 30 % (w/w) | |
| Trade name(s) | desmanol pure universal | Market area: EU | |||
| --- | --- | --- | --- | --- | --- |
| desmanol pure plus | Market area: EU | ||||
| desmanol pure expert | Market area: EU | ||||
| desmanol proshield | Market area: EU | ||||
| desmanol healthcare | Market area: EU | ||||
| desmanol duo | Market area: EU | ||||
| desmanol EtOH-free | Market area: EU | ||||
| desmanol zero | Market area: EU | ||||
| sensiva pure+ | Market area: EU | ||||
| virusept expert | Market area: EU | ||||
| septoderm pure+ | Market area: EU | ||||
| microshield pure+ | Market area: EU | ||||
| Halasept 740 | 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 % (w/w) | |
| Propan-1-ol | Active substance | 71-23-8 | 200-746-9 | 30 % (w/w) |