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)
Date: 2022-07-08
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, decontamination, food safety, market approval, pharmaceutical product








L_2022195EN.01003401.xml










22.7.2022   


EN


Official Journal of the European Union


L 195/34








            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)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5), first subparagraph, thereof,

Whereas:







(1)


On 17 April 2019, Knieler & Team GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Knieler & Team Propanol Family’ of product-types 1, 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Switzerland had agreed to evaluate the application. The application was recorded under case number BC-AQ050985-22 in the Register for Biocidal Products.












(2)


‘Knieler & Team Propanol Family’ contains propan-1-ol and propan-2-ol, as the active substances, which are included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 1, 2 and 4.












(3)


On 29 March 2021, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).












(4)


On 4 November 2021, the Agency submitted to the Commission an opinion (2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘Knieler & Team Propanol Family’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.












(5)


The opinion concludes that ‘Knieler & Team Propanol Family’ is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.












(6)


On 22 November 2021, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.












(7)


The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Knieler & Team Propanol Family’.












(8)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on biocidal products,





HAS ADOPTED THIS REGULATION:



Article 1
A Union authorisation with authorisation number EU-0027467-0000 is granted to Knieler & team GmbH for the making available on the market and use of the biocidal product family ‘Knieler & Team Propanol Family’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 11 August 2022 to 31 July 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.
Done at Brussels, 8 July 2022.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1.

(2)  ECHA opinion of 7 October 2021 on the Union authorisation of ‘Knieler & Team Propanol Family’ (ECHA/BPC/292/2021), https://echa.europa.eu/bpc-opinions-on-union-authorisation.




ANNEX
Summary of product characteristics for a biocidal product family
Knieler & Team Propanol Family
Product type 1 - Human hygiene (Disinfectants)
Product type 2 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Product type 4 - Food and feed area (Disinfectants)
Authorisation number: EU-0027467-0000
R4BP asset number: EU-0027467-0000
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


Table 1


Use # 1 – hygienic handrub, liquid







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, 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) 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

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.
Do not refill.
4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 1
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

See general directions for use of meta SPC 1
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 1
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 1
4.2.   Use description


Table 2


Use # 2 – surgical handrub, liquid







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

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.
Do not refill.
4.2.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 1
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

See general directions for use of meta SPC 1
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 1
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 1
5.   GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1
5.1.   Instructions for use

For professional use only.
5.2.   Risk mitigation measures

Avoid contact with eyes.
Keep out of reach of children.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention if you feel unwell. If possible, show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
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 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.
Accidental release measures:
Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames. No smoking.
Prevent entry to sewers and public waters.
Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations.
5.4.   Instructions for safe disposal of the product and its packaging

Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior to disposal. When totally empty, containers are recyclable like any other packing.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0-30°C
Do not store at temperatures below 0°C
Do not store near food, drink and animal feedingstuff. Keep away from combustible material.
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


Table 3


Use # 1 – hygienic handrub, liquid







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, 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). 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

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.
Do not refill.
4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 2
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

See general directions for use of meta SPC 2
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 2
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 2.
4.2.   Use description


Table 4


Use # 2 – surgical handrub, liquid







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

The product can be applied directly or the product 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.
Do not refill.
4.2.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 2
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

See general directions for use of meta 2
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta 2
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta 2
5.   GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2
5.1.   Instructions for use

For professional use only.
5.2.   Risk mitigation measures

Avoid contact with eyes.
Keep out of reach of children.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention if you feel unwell. If possible, show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
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 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.
Accidental release measures:
Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames. No smoking.
Prevent entry to sewers and public waters.
Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations.
5.4.   Instructions for safe disposal of the product and its packaging

Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior to disposal. When totally empty, containers are recyclable like any other packing.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0-30°C
Do not store at temperatures below 0°C
Do not store near food, drink and animal feeding stuff. Keep away from combustible material.
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


Table 5


Use # 1 – hygienic handrub, liquid







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, 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). 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

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.
Do not refill.
4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 3
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

See general directions for use of meta SPC 3
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 3
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 3
4.2.   Use description


Table 6


Use # 2 – surgical handrub, liquid







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

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.
Do not refill.
4.2.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 3
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

See general directions for use of meta SPC 3
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 3
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 3
5.   GENERAL DIRECTIONS FOR USE (3) OF THE META SPC 3
5.1.   Instructions for use

For professional use only.
5.2.   Risk mitigation measures

Avoid contact with eyes.
Keep out of reach of children.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention if you feel unwell. If possible, show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
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 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.
Accidental release measures:
Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames. No smoking.
Prevent entry to sewers and public waters.
Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations.
5.4.   Instructions for safe disposal of the product and its packaging

Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior to disposal. When totally empty, containers are recyclable like any other packing.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0-30°C
Do not store at temperatures below 0°C
Do not store near food, drink and animal feedingstuff. Keep away from combustible material.
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


Table 7


Use # 1 – hygienic handrub, gel







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, 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). 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

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.
Do not refill.
4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 4
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

See general directions for use of meta SPC 4
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 4
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 4
4.2.   Use description


Table 8


Use # 2 – surgical handrub, gel







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

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.
Do not refill.
4.2.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 4
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

See general directions for use of meta SPC 4
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 4
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 4
5.   GENERAL DIRECTIONS FOR USE (4) OF THE META SPC 4
5.1.   Instructions for use

For professional use only.
5.2.   Risk mitigation measures

Avoid contact with eyes.
Keep out of reach of children.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention if you feel unwell. If possible, show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
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 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.
Accidental release measures: Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames. No smoking.Prevent entry to sewers and public waters. Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations.
5.4.   Instructions for safe disposal of the product and its packaging

Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior to disposal. When totally empty, containers are recyclable like any other packing.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0-30°C
Do not store at temperatures below 0°C
Do not store near food, drink and animal feedingstuff. Keep away from combustible material.
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


Table 9


Use # 1 – hygienic handrub, gel







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, 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). 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

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.
Do not refill.
4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 5
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

See general directions for use of meta SPC 5
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 5
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 5
4.2.   Use description


Table 10


Use # 2 – surgical handrub, gel







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

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.
Do not refill.
4.2.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 5
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

See general directions for use of meta SPC 5
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 5
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 5
5.   GENERAL DIRECTIONS FOR USE (5) OF THE META SPC 5
5.1.   Instructions for use

For professional use only.
5.2.   Risk mitigation measures

Avoid contact with eyes.
Keep out of reach of children.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention if you feel unwell. If possible, show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
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 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.
Accidental release measures:
Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames. No smoking.
Prevent entry to sewers and public waters.
Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations.
5.4.   Instructions for safe disposal of the product and its packaging

Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior to disposal. When totally empty, containers are recyclable like any other packing.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0-30°C
Do not store at temperatures below 0°C
Do not store near food, drink and animal feedingstuff. Keep away from combustible material.
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


Table 11


Use # 1 – hard non-porous small surface disinfection RTU liquid







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

Surfaces should always be visibly clean prior to disinfection. Maximum number of applications is 6 per day.
4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 6
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

See general directions for use of meta SPC 6
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 6
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 6
4.2.   Use description


Table 12


Use # 2 – hard non-porous small surface disinfection RTU liquid







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

Surfaces should always be visibly clean prior to disinfection.
4.2.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 6
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

See general directions for use of meta SPC 6
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 6
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 6
5.   GENERAL DIRECTIONS FOR USE (6) OF THE META SPC 6
5.1.   Instructions for use

For professional use only.
5.2.   Risk mitigation measures

The use of eye protection during handling of the product is mandatory.
Keep out of reach of children
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention if you feel unwell. If possible, show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
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 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.
Accidental release measures: Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames. No smoking. Prevent entry to sewers and public waters. Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations.
5.4.   Instructions for safe disposal of the product and its packaging

Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior to disposal. When totally empty, containers are recyclable like any other packing.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0-30°C
Do not store at temperatures below 0°C
Do not store near food, drink and animal feedingstuff. Keep away from combustible material.
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


Table 13


Use # 1 – hard non-porous small surface disinfection RTU liquid







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

Surfaces should always be visibly clean prior to disinfection. Maximum number of applications is 6 per day.
4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 7
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

See general directions for use of meta SPC 7
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 7
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 7
4.2.   Use description


Table 14


Use # 2 – hard non-porous small surface disinfection RTU liquid







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

Surfaces should always be visibly clean prior to disinfection.
4.2.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 7
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

See general directions for use of meta SPC 7
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 7
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 7
5.   GENERAL DIRECTIONS FOR USE (7) OF THE META SPC 7
5.1.   Instructions for use

For professional use only.
5.2.   Risk mitigation measures

The use of eye protection during handling of the product is mandatory.
Keep out of reach of children.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention if you feel unwell. If possible show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
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 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.
Accidental release measures:Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames. No smoking.Prevent entry to sewers and public waters.Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations.
5.4.   Instructions for safe disposal of the product and its packaging

Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior to disposal. When totally empty, containers are recyclable like any other packing.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0-30°C
Do not store at temperatures below 0°C
Do not store near food, drink and animal feedingstuff. Keep away from combustible material.
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


Table 15


Use # 1 – hard non-porous small surface disinfection RTU wipes







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

Surfaces should always be visibly clean prior to disinfection. Maximum number of applications is 6 per day.
4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 8.
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

See general directions for use of meta SPC 8.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 8
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 8
4.2.   Use description


Table 16


Use # 2 – hard non-porous small surface disinfection RTU wipes







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
Surfaces should always be visibly clean prior to disinfection.
4.2.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 8
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

See general directions for use of meta SPC 8
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 8
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 8
5.   GENERAL DIRECTIONS FOR USE (8) OF THE META SPC 8
5.1.   Instructions for use

For professional use only.
For wipes reseal the package after opening.
5.2.   Risk mitigation measures

Avoid contact with eyes.
Keep out of reach of children.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention if you feel unwell. If possible show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
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 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.
Accidental release measures:
Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames. No smoking.
Prevent entry to sewers and public waters.
Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations.
5.4.   Instructions for safe disposal of the product and its packaging

Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior to disposal. When totally empty, containers are recyclable like any other packing.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0-30°C
Do not store at temperatures below 0°C
Do not store near food, drink and animal feedingstuff. Keep away from combustible material.
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


Table 17


Use # 1 – hard non-porous small surface disinfection RTU wipes







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

Surfaces should always be visibly clean prior to disinfection. Maximum number of applications is 6 per day.
4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 9
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

See general directions for use of meta SPC 9
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 9
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use of meta SPC 9
4.2.   Use description


Table 18


Use # 2 – hard non-porous small surface disinfection RTU wipes







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

Surfaces should always be visibly clean prior to disinfection.
4.2.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 9
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

See general directions for use of meta SPC 9
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 9
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

ee general directions for use of meta SPC 9
5.   GENERAL DIRECTIONS FOR USE (9) OF THE META SPC 9
5.1.   Instructions for use

For professional use only.
For wipes reseal the package after opening.
5.2.   Risk mitigation measures

Avoid contact with eyes.
Keep out of reach of children
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention if you feel unwell. If possible, show this sheet.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
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 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.
Accidental release measures:Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames. No smoking.Prevent entry to sewers and public waters.Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations.
5.4.   Instructions for safe disposal of the product and its packaging

Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior to disposal. When totally empty, containers are recyclable like any other packing.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months
Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.
Recommended storage temperature: 0-30°C
Do not store at temperatures below 0°C
Do not store near food, drink and animal feeding stuff. Keep away from combustible material.
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 






(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.

(2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.

(3)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.

(4)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.

(5)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 5.

(6)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 6.

(7)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 7.

(8)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 8.

(9)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 9.