Commission Implementing Regulation (EU) 2024/2194 of 4 September 2024 amending Implementing Regulation (EU) 2020/1991 as regards administrative and minor changes to the Union authorisation for the biocidal product family perform-IPA
Date: 2024-09-04
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal health, biocide, chemical product, decontamination, food safety, health control, market approval








L_202402194EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2024/2194


5.9.2024







            COMMISSION IMPLEMENTING REGULATION (EU) 2024/2194
of 4 September 2024
         
amending Implementing Regulation (EU) 2020/1991 as regards administrative and minor changes to the Union authorisation for the biocidal product family ‘perform-IPA’
         
(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 50(2) thereof,

Whereas:







(1)


On 27 November 2020, a Union authorisation with authorisation number EU-0023656-0000 was granted to Schülke & Mayr GmbH for the making available on the market and use of the biocidal product family ‘perform IPA’ by Commission Implementing Regulation (EU) 2020/1991 (2). The Annex to that Implementing Regulation provides the summary of product characteristics (‘SPC’) for the biocidal product family ‘perform-IPA’ in accordance with Article 22 of Regulation (EU) No 528/2012.












(2)


Commission Implementing Regulation (EU) No 354/2013 (3) provides for the procedural rules for the different categories of changes referred to in Article 50(3) of Regulation (EU) No 528/2012. On receipt of an opinion from the European Chemicals Agency (‘the Agency’) on an application from an authorisation holder of a Union authorisation, seeking to change any of the information submitted for the initial application for authorisation, the Commission is to decide whether the conditions of Article 19 or, where relevant, Article 25 of Regulation (EU) No 528/2012 are still met and whether the terms and conditions of the authorisation are required to be amended.












(3)


On 20 December 2021, Schülke & Mayr GmbH submitted to the Agency a notification of administrative changes in accordance with Article 11(1) of Implementing Regulation (EU) No 354/2013, recorded in the register for biocidal products (‘the Register’) under case number BC-AB072184-64, and an application for a minor change in accordance with Article 12(1) of that Implementing Regulation, recorded in the Register under case number BC-SN072185-20, to the Union authorisation for the biocidal product family ‘perform-IPA’. In respect of the administrative changes, Schülke & Mayr GmbH notified a change in the administrative details of two of the product formulators, the addition of five product formulators, the addition of a trade name in the section meta-SPC 1 of the SPC and the removal of a claim that products can be used in clean rooms class A/B in the sections meta-SPC 1 to 6 of the SPC. Regarding the minor change, Schülke & Mayr GmbH applied for a change of the pack-size range (all for the sections meta-SPC 1 and 3 of the SPC: extension of pack size range for canisters from 5-10 L to 5-30 L, addition of 200-220 L HDPE drums and addition of 900-1000 L containers (IBC)).












(4)


On 1 February 2023, Schülke & Mayr GmbH submitted to the Agency an application for a further minor change to the Union authorisation for the biocidal product family ‘perform-IPA’ in accordance with Article 12(1) of Implementing Regulation (EU) No 354/2013, recorded in the Register under case number BC-NJ084251-38, for the addition of a claim for limited spectrum virucidal activity to all product-type 2 uses (disinfectants and algaecides not intended for direct application to humans and animals) in the sections meta-SPC 1 to 6 of the SPC.












(5)


On 11 February 2022, the Agency submitted an opinion (4) to the Commission on the notified administrative changes to the Union authorisation for the biocidal product family ‘perform-IPA’, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, together with a revised summary of the biocidal product characteristics. The opinion concludes that the proposed changes are administrative changes in accordance with Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 1 of the Annex to Implementing Regulation (EU) No 354/2013, and that after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 are still met. On 7 March 2022, the Agency transmitted to the Commission the revised summary of biocidal product characteristics of the Union authorisation for the biocidal product family ‘perform-IPA’ in all official languages of the Union covering all administrative changes applied for, in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.












(6)


On 10 October 2023, the Agency submitted its opinions (5) to the Commission on the two applications for minor changes to the Union authorisation for the biocidal product family ‘perform-IPA’, in accordance with Article 12(4) of Implementing Regulation (EU) No 354/2013, together with a revised summary of the biocidal product characteristics and a revised assessment report concluding that the proposed changes are minor changes in accordance with Article 50(3), point (b), of Regulation (EU) No 528/2012 and as specified in Title 2 of the Annex to Implementing Regulation (EU) No 354/2013, and that after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 are still met.












(7)


On 10 November 2023, the Agency transmitted to the Commission the revised summary of biocidal product characteristics of the Union authorisation for the biocidal product family ‘perform-IPA’ in all official languages of the Union covering all administrative and minor changes applied for, in accordance with Article 12(6) of Implementing Regulation (EU) No 354/2013.












(8)


The Commission concurs with the opinions of the Agency and therefore considers it appropriate to amend the Union authorisation for the biocidal product family ‘perform-IPA’ to introduce the administrative and minor changes requested by Schülke & Mayr GmbH.












(9)


Except for the amendments regarding the administrative and minor changes, all other information included in the summary of the biocidal product characteristics of ‘perform-IPA’ as set out in the Annex to Implementing Regulation (EU) 2020/1991 remains unchanged.












(10)


In order to enhance clarity and to ease the access of users and interested parties to the final consolidated version of the summary of biocidal product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2020/1991 should be replaced in its entirety.












(11)


Implementing Regulation (EU) 2020/1991 should therefore be amended accordingly,





HAS ADOPTED THIS REGULATION:



Article 1
The Annex to Implementing Regulation (EU) 2020/1991 is replaced by the text in the Annex to this Regulation.


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, 4 September 2024.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1; ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(2)  Commission Implementing Regulation (EU) 2020/1991 of 27 November 2020 granting a Union authorisation for the biocidal product family ‘perform-IPA’ (OJ L 410, 7.12.2020, p. 1; ELI: http://data.europa.eu/eli/reg_impl/2020/1991/oj).

(3)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4; ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj).

(4)  ECHA Opinion on the administrative change of the Union authorisation of the biocidal product family: perform-IPA of 11 February 2022, Opinion N° UAD-C-1560029-43-00/F, https://echa.europa.eu/opinions-on-union-authorisation.

(5)  Biocidal Products Committee (BPC) opinion on the minor change to the Union authorisation of the biocidal product family ‘perform-IPA’, 10 October 2023, ECHA/BPC/397/2023 and BPC opinion on the minor change to the Union authorisation of the biocidal product family ‘perform-IPA’, 10 October 2023, ECHA/BPC/400/2023, https://echa.europa.eu/opinions-on-union-authorisation.




ANNEX
Summary of product characteristics for a biocidal product family
perform-IPA
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-0023656-0000
R4BP asset number: EU-0023656-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name







Name


perform-IPA




1.2.   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)




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


Schuelke & Mayr GmbH




Address


Robert-Koch-Str. 2, 22851 Norderstedt Germany




Authorisation number


EU-0023656-0000





R4BP asset number



EU-0023656-0000




Date of the authorisation


27 December 2020




Expiry date of the authorisation


30 November 2030




1.4.   Manufacturer(s) of the biocidal products







Name of manufacturer


Schülke & Mayr GmbH




Address of manufacturer


Robert-Koch-Str. 2, 22851 Norderstedt Germany




Location of manufacturing sites


Robert-Koch-Str. 2, 22851 Norderstedt Germany













Name of manufacturer


BOCHEMIE a.s.




Address of manufacturer


Lidická 326, 735 95 Bohumín Czech Republic




Location of manufacturing sites


Lidická 326, 735 95 Bohumín Czech Republic













Name of manufacturer


Imeco




Address of manufacturer


Am Sägewerk 10, 63773 Goldbach Germany




Location of manufacturing sites


Boschstr. 5, 63768 Hösbach Germany
Neue Straße 2-4, 09471 Köningswalde Germany
Am Gansberg 9, 09481 Elterlein Germany
ul.Wlo'kiennicza 10, 59-800 Luban Poland













Name of manufacturer


Tristel Solutions Limited




Address of manufacturer


Lynx Business Park, Fordham Road, Snailwell, CB8 7NY Cambridgeshire United Kingdom




Location of manufacturing sites


Lynx Business Park, Fordham Road, Snailwell, CB8 7NY Cambridgeshire United Kingdom













Name of manufacturer


Techtex




Address of manufacturer


Units 7&8 Rhodes Bus. Park Silburn Way, M24 4NE Middleton United Kingdom




Location of manufacturing sites


Units 7&8 Rhodes Bus. Park Silburn Way, M24 4NE Middleton United Kingdom













Name of manufacturer


A.F.P. GmbH




Address of manufacturer


Otto Brenner Straße 16, 21337 Lüneburg Germany




Location of manufacturing sites


Otto Brenner Straße 16, 21337 Lüneburg Germany













Name of manufacturer


Innovate GmbH




Address of manufacturer


Gewerbegebietsstraße 30, 06618 Schönburg Germany




Location of manufacturing sites


Gewerbegebietsstraße 30, 06618 Schönburg Germany
Keizersveld 99, 5803 AP Venray Netherlands













Name of manufacturer


Lysoform Dr. Hans Rosemann GmbH




Address of manufacturer


Kaiser-Wilhelm-Straße 133, 12247 Berlin Germany




Location of manufacturing sites


Kaiser-Wilhelm-Straße 133, 12247 Berlin Germany













Name of manufacturer


Sterisol AB




Address of manufacturer


Kronoängsgatan 3, 592 23 Vadstena Sweden




Location of manufacturing sites


Kronoängsgatan 3, 592 23 Vadstena Sweden













Name of manufacturer


Rudolf Dankwardt GmbH




Address of manufacturer


Gutenbergring 50-52, 22848 Norderstedt Germany




Location of manufacturing sites


Gutenbergring 50-52, 22848 Norderstedt Germany
Lagerstr. 15, 19249 Jessenitz - Werk / Lübtheen Germany













Name of manufacturer


BIOXAL SA




Address of manufacturer


ZI Sud Secteur A, Route des Varennes, 71100 Chalon sur Saône France




Location of manufacturing sites


ZI Sud Secteur A, Route des Varennes, 71100 Chalon sur Saône France













Name of manufacturer


Lichtenheldt GmbH




Address of manufacturer


Industriestrasse 7-9, 23812 Wahlstedt Germany




Location of manufacturing sites


Industriestrasse 7-9, 23812 Wahlstedt Germany
Justus-Liebig-Weg 1, 23812 Wahlstedt Germany













Name of manufacturer


NATURELLE CONSUMER PRODUCTS LTD




Address of manufacturer


Unit 5 Bankmore Way, East industrial Park,, BT79 ONZ Doogary, Omagh, Co. Tyrone United Kingdom




Location of manufacturing sites


Unit 5 Bankmore Way, East industrial Park,, BT79 ONZ Doogary, Omagh, Co. Tyrone United Kingdom













Name of manufacturer


Halag Chemie AG




Address of manufacturer


Weiernstrasse 30, 8355 Aadorf Switzerland




Location of manufacturing sites


Weiernstrasse 30, 8355 Aadorf Switzerland













Name of manufacturer


PDI (EMEA) Ltd




Address of manufacturer


Pywell Rd Willowbrook East Industrial Estate, NN17 5XJ Corby United Kingdom




Location of manufacturing sites


Pywell Rd Willowbrook East Industrial Estate, NN17 5XJ Corby United Kingdom




1.5.   Manufacturer(s) of the active substance(s)







Active substance


Propan-2-ol




Name of manufacturer


Ineos Solvents Germany GmbH (formerly Sasol)




Address of manufacturer


Römerstraße 733, 47443 Moers Germany




Location of manufacturing sites


Römerstraße 733, 47443 Moers Germany
Shamrockstr. 88, 44643 Herne Germany













Active substance


Propan-2-ol




Name of manufacturer


Shell Chemicals Europe B.V.




Address of manufacturer


Postbus 2334, 3000 CH Rotterdam Netherlands




Location of manufacturing sites


Shell Nederland Raffinaderij B.V., Vondelingenweg 601, 3196 KK Rotterdam-Pernis Netherlands




2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the family












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,1


63,1




2.2.   Type(s) of formulation







Formulation(s)


Any other liquid (AL), ready-to-use
Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation




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 perform IPA liquid




1.2.   Suffix to the authorisation number







Number


1-1




1.3.   Product type(s)







Product type(s)


PT04 - Food and feed area (Disinfectants)
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




2.   META SPC 1 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 1












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,1


63,1




2.2.   Type(s) of formulation of the meta SPC 1







Formulation(s)


Any other liquid (AL), ready-to-use




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1







Hazard statements


Highly flammable liquid and vapour.
Causes serious eye irritation.
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.
Ground and bond container and receiving equipment.
Use explosion-proof electrical/ventilating/lighting equipment.
Use non-sparking tools.
Take action to prevent static discharges.
Avoid breathing vapours.
Avoid breathing spray.
Use only outdoors or in a well-ventilated area.
Wear eye protection.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Call a POISON CENTER or doctor if you feel unwell.
If eye irritation persists:Get medical advice.
If eye irritation persists:Get medical attention.
In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of contents to /container to an approved waste disposal plant.




4.   AUTHORISED USE(S) OF THE META SPC 1

4.1.   Use description



Table 1



Use # 1 – Disinfection of surfaces - spraying







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


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: viruses (limited spectrum virucidal activity)
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas




Application method(s)


Method: Spraying
Detailed description:
Product will be sprayed directly on the surface




Application rate(s) and frequency


Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.
Dilution (%): -
Number and timing of application:
Disinfection after each production and cleaning process or when required according to standard operating procedure (SOP)




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Bottle: 250-1000 ml
packaging material: high-density polyethylene (HDPE), surlyn/polypropylene (PP)
closure material is either: PP, polyoxymethylene (POM), low-density polyethylene (LDPE), HDPE, polyethylene (PE), ethylene-vinyl acetate (EVA), stainless steel, polybutylene terephthalate (PBT), (LD)PE, exp. polytetrafluoroethylene (PTFE), linear low density polyethylene (LLDPE), expanded PE (EXPPE), Co Polymer PP
canister: 5-30 litre
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 litre
packaging material: EVA
closure material: PP/Silicone/EVA
drum: 200 - 220 litre
packaging material: HDPE
closure material is either: PP
IBC: 900-1000 litre
packaging material: HDPE with steel frame
closure material is either: PP, HDPE




4.1.1.   Use-specific instructions for use

Spray ready-to-use product on the surface and allow to take effect at 20± 2°C for at least 1 minute (bactericidal and yeasticidal activity) or 2 minutes (limited spectrum virucidal activity).
4.1.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.
4.2.   Use description



Table 2



Use # 2 – Disinfection of surfaces - wiping







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


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: viruses (limited spectrum virucidal activity)
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas




Application method(s)


Method: Wiping
Detailed description:
Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on the surface.




Application rate(s) and frequency


Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.
Dilution (%): -
Number and timing of application:
Disinfection after each production and cleaning process or when required according to SOP.




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Bottle: 250-1000 ml
packaging material: HDPE, surlyn/PP
closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP. ﻿
canister: 5-30 litre
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 litre
packaging material: EVA
closure material: PP/Silicone/EVA.
drum: 200 - 220 litre
packaging material: HDPEclosure material is either: PP
IBC: 900-1000 litre
packaging material: HDPE with steel frameclosure material is either: PP, HDPE




4.2.1.   Use-specific instructions for use

Spray or pour ready-to-use product on the surface and wipe afterwards or wet a wipe with the ready-to-use product by spraying or pouring and thereafter wipe the surface. Allow to take effect at 20 ± 2°C for at least 5 minutes (bactericidal, yeasticidal and limited spectrum virucidal activity).
4.2.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.
4.3.   Use description



Table 3



Use # 3 – Disinfection of surfaces with food and feed contact - spraying







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Viruses
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of clean non-porous surfaces in kitchens and food industry




Application method(s)


Method: Spraying
Detailed description:
Product will be sprayed directly on the surface.




Application rate(s) and frequency


Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.
Dilution (%): -
Number and timing of application:
Disinfection after each production and cleaning process or when required according to SOP.




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Bottle: 250-1000 ml
packaging material: HDPE, surlyn/PP
closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP. ﻿
canister: 5-30 litre
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 litre
packaging material: EVA
closure material: PP/Silicone/EVA.
drum: 200 - 220 litre
packaging material: HDPEclosure material is either: PP
IBC: 900-1000 litre
packaging material: HDPE with steel frame
closure material is either: PP, HDPE




4.3.1.   Use-specific instructions for use

Spray ready-to-use product on the surface and allow to take effect at room temperature (20± 2°C) for at least 1 (bactericidal and yeasticidal activity) or 2 minutes (virucidal activity).
4.3.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
4.3.3.   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.
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

4.3.5.   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.
4.4.   Use description



Table 4



Use # 4 – Disinfection of surfaces with food and feed contact - wiping







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Viruses
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of clean non-porous surfaces in kitchens and food industry




Application method(s)


Method: Wiping
Detailed description:
Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on the surface.




Application rate(s) and frequency


Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.
Dilution (%): -
Number and timing of application:
Disinfection after each production and cleaning process or when required according to SOP.




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Bottle: 250-1000 ml﻿
packaging material: HDPE, surlyn/PP
closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP. ﻿
canister: 5-30 litre
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 litre
packaging material: EVA
closure material: PP/Silicone/EVA.
drum: 200 - 220 litre
packaging material: HDPE closure material is either: PP
IBC: 900-1000 litre
packaging material: HDPE with steel frame closure material is either: PP, HDPE




4.4.1.   Use-specific instructions for use

Spray ready-to-use product on the surface and wipe afterwards or wet a wipe with the ready-to-use product by spraying or pouring and thereafter wipe the surface. Allow to take effect for at least 5 minutes at room temperature (20± 2°C).
4.4.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
4.4.3.   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.
4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

4.4.5.   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.
5.   GENERAL DIRECTIONS FOR USE (1)
OF THE META SPC 1

5.1.   Instructions for use

Clean the surface carefully before use.
Remove excess water from the surface before disinfection, if appropriate.
Do not apply more than 25 ml/m2.
Make sure to wet surfaces completely.
Used wipes must be disposed in a closed container.
5.2.   Risk mitigation measures

The product must only be applied for disinfection of small surfaces.
Ensure adequate ventilation to prevent the formation of explosive atmospheres.
Avoid contact with eyes.
Apply a funnel for refilling.
Keep out of reach of children and pets.
Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:
In case of accident: Call a poison centre or a doctor.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
If on skin: Wash with water. If skin irritation occurs: Get medical advice.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
5.4.   Instructions for safe disposal of the product and its packaging

-
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 36 months
Keep container tightly closed.
Store in a well-ventilated place.
Protect from sunlight.
Store at room temperature in the original container.
6.   OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
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)


perform® sterile alcohol IPA


Market area: EU




 


perform® classic alcohol IPA


Market area: EU




buraton® IPA


Market area: EU




perform® advanced alcohol IPA


Market area: EU




arcana® IPA


Market area: EU




clear IPA


Market area: EU




pure IPA


Market area: EU




disinfectant IPA


Market area: EU




Surface disinfection liquid classic


Market area: EU




sterile IPA


Market area: EU




mikrozid® sterile liquid


Market area: EU




Surface disinfection liquid sterile


Market area: EU




BTS 6000


Market area: EU




Halades Alco


Market area: EU




Authorisation number


EU-0023656-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,1





META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier







Identifier


meta SPC 2 perform wipes IPA




1.2.   Suffix to the authorisation number







Number


1-2




1.3.   Product type(s)







Product type(s)


PT04 - Food and feed area (Disinfectants)
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




2.   META SPC 2 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 2












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,1


63,1




2.2.   Type(s) of formulation of the meta SPC 2







Formulation(s)


Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2







Hazard statements


Highly flammable liquid and vapour.
Causes serious eye irritation.
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.
Ground and bond container and receiving equipment.
Use explosion-proof electrical/ventilating/lighting equipment.
Use non-sparking tools.
Take action to prevent static discharges.
Avoid breathing vapours.
Avoid breathing spray.
Use only outdoors or in a well-ventilated area.
Wear eye protection.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Call a POISON CENTER or doctor if you feel unwell.
If eye irritation persists:Get medical advice.
If eye irritation persists:Get medical attention.
In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of contents to /container to an approved waste disposal plant.




4.   AUTHORISED USE(S) OF THE META SPC 2

4.1.   Use description



Table 5



Use # 1 – Disinfection of surfaces - wiping







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


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: viruses (limited spectrum virucidal activity)
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas




Application method(s)


Method: Wiping
Detailed description:
Product will be wiped directly on the surface.




Application rate(s) and frequency


Application Rate: Ready-to-use wipes
Dilution (%): -
Number and timing of application:
Disinfection after each production and cleaning process or when required according to SOP.




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Soft pack: 1-200 wipes
Packaging material: LDPE/Alu/PET; LDPE/PET; biaxially oriented polypropylene (BOPP) + cast polypropylene (CPP)
Pouch: 10-200 wipes
Packaging material: LDPE/PET
Tube: 50-200 wipes
Packaging material: HDPE﻿
closure material is either PP, PE3385




4.1.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect at 20 ± 2°C for at least 5 minutes (bactericidal, yeasticidal and limited spectrum virucidal activity).
4.1.2.   Use-specific risk mitigation measures

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

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.
4.2.   Use description



Table 6



Use # 2 – Disinfection of surfaces with food and feed contact - wiping







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Viruses
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of clean non-porous surfaces in kitchens and food industry




Application method(s)


Method: Wiping
Detailed description:
Product will be wiped directly on the surface.




Application rate(s) and frequency


Application Rate: Ready-to-use wipes
Dilution (%): -
Number and timing of application:
Disinfection after each production and cleaning process or when required according to SOP.




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Soft pack: 1-200 wipes
Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
Pouch: 10-200 wipes
Packaging material: LDPE/PET
Tube: 50-200 wipes
Packaging material: HDPE
closure material is either PP, PE3385




4.2.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).
4.2.2.   Use-specific risk mitigation measures

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

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

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

5.1.   Instructions for use

Clean the surface carefully before use.
Remove excess water from the surface before disinfection, if appropriate.
Make sure to wet surfaces completely.
Used wipes must be disposed in a closed container.
5.2.   Risk mitigation measures

The product must only be applied for disinfection of small surfaces.
Ensure adequate ventilation to prevent the formation of explosive atmospheres.
Avoid contact with eyes.
Keep out of reach of children and pets.
Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:
In case of accident: Call a poison centre or a doctor.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
If on skin: Wash with water. If skin irritation occurs: Get medical advice.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
5.4.   Instructions for safe disposal of the product and its packaging

-
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months
Keep container tightly closed.
Store in a well-ventilated place.
Protect from sunlight.
Store at room temperature in the original container.
6.   OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
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)


perform classic wipes IPA


Market area: EU




 


buraton® wipes IPA


Market area: EU




perform® advanced wipes IPA


Market area: EU




arcana® wipes IPA


Market area: EU




clear IPA wipes


Market area: EU




pure IPA wipes


Market area: EU




disinfectant IPA wipes


Market area: EU




Surface disinfection wipes classic


Market area: EU




perform® sterile wipes IPA


Market area: EU




sterile IPA wipes


Market area: EU




mikrozid® sterile wipes


Market area: EU




Surface disinfection wipes sterile


Market area: EU




Authorisation number


EU-0023656-0002 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,1





META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier







Identifier


meta SPC 3 mikrozid liquid




1.2.   Suffix to the authorisation number







Number


1-3




1.3.   Product type(s)







Product type(s)


PT04 - Food and feed area (Disinfectants)
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (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-2-ol


 


Active Substance


67-63-0


200-661-7


63,1


63,1




2.2.   Type(s) of formulation of the meta SPC 3







Formulation(s)


Any other liquid (AL), ready-to-use




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3







Hazard statements


Highly flammable liquid and vapour.
Causes serious eye irritation.
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.
Ground and bond container and receiving equipment.
Use explosion-proof electrical/ventilating/lighting equipment.
Use non-sparking tools.
Take action to prevent static discharges.
Avoid breathing vapours.
Avoid breathing spray.
Use only outdoors or in a well-ventilated area.
Wear eye protection.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Call a POISON CENTER or doctor if you feel unwell.
If eye irritation persists:Get medical advice.
If eye irritation persists:Get medical attention.
In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of contents to /container to an approved waste disposal plant.




4.   AUTHORISED USE(S) OF THE META SPC 3

4.1.   Use description



Table 7



Use # 1 – Disinfection of surfaces - spraying







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


-




Target organism(s) (including development stage)


Scientific name: Bacteria including Mycobacterium tuberculosis
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: viruses (limited spectrum virucidal activity)
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas




Application method(s)


Method: Spraying
Detailed description:
Product will be sprayed directly on the surface




Application rate(s) and frequency


Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.
Dilution (%): -
Number and timing of application:
Disinfection when required according to SOP.




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Bottle: 250-1000 ml
packaging material: HDPE, surlyn/PP
closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP
canister: 5-30 litre
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 litre
packaging material: EVA
Closure : PP/Silicone/EVA
drum: 200 - 220 litre
packaging material: HDPE
closure material is either: PP
IBC:900-1000 litre
packaging material: HDPE with steel frame closure material is either: PP, HDPE




4.1.1.   Use-specific instructions for use

Spray ready-to-use product on the surface and allow to take effect at 20± 2°C for at least 1 minute (bactericidal and yeasticidal activity) or 2 minutes (limited spectrum virucidal activity).
4.1.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.
4.2.   Use description



Table 8



Use # 2 – Disinfection of surfaces - wiping







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


-




Target organism(s) (including development stage)


Scientific name: Bacteria including Mycobacterium tuberculosis
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: viruses (limited spectrum virucidal activity)
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas




Application method(s)


Method: Wiping
Detailed description:
Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on the surface.




Application rate(s) and frequency


Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.
Dilution (%): -
Number and timing of application:
Disinfection when required according to SOP.




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Bottle: 250-1000 ml
packaging material: HDPE, surlyn/PP
closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP
canister: 5-30 litre
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 litre
packaging material: EVA
Closure : PP/Silicone/EVA
drum: 200 - 220 litre
packaging material: HDPE
closure material is either: PP
IBC:900-1000 litre
packaging material: HDPE with steel frame
closure material is either: PP, HDPE




4.2.1.   Use-specific instructions for use

Spray or pour ready-to-use product on the surface and wipe afterwards or wet a wipe with the ready-to-use product by spraying or pouring and thereafter wipe the surface. Allow to take effect at 20 ± 2°C for at least 5 minutes (bactericidal, yeasticidal and limited spectrum virucidal activity).
4.2.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.
4.3.   Use description



Table 9



Use # 3 – Disinfection of surfaces with food and feed contact - spraying







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria including Mycobacterium tuberculosis
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Viruses
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of clean non-porous surfaces in kitchens and food industry




Application method(s)


Method: Spraying
Detailed description:
Product will be sprayed directly on the surface.




Application rate(s) and frequency


Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.
Dilution (%): -
Number and timing of application:
Disinfection when required according to SOP.




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Bottle: 250-1000 ml
packaging material: HDPE, surlyn/PP
closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP
canister: 5-30 litre
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 litre
packaging material: EVA
Closure : PP/Silicone/EVA
drum: 200 - 220 litre
packaging material: HDPE
closure material is either: PP
IBC: 900-1000 litre
packaging material: HDPE with steel frame closure material is either: PP, HDPE




4.3.1.   Use-specific instructions for use

Spray ready-to-use product on the surface and allow to take effect at room temperature (20± 2°C) for at least 1 (bactericidal and yeasticidal activity) or 2 minutes (virucidal activity).
4.3.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
4.3.3.   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.
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

4.3.5.   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.
4.4.   Use description



Table 10



Use # 4 – Disinfection of surfaces with food and feed contact - wiping







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria including Mycobacterium tuberculosis
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Viruses
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of clean non-porous surfaces in kitchens and food industry




Application method(s)


Method: Wiping
Detailed description:
Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on surface.




Application rate(s) and frequency


Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.
Dilution (%): -
Number and timing of application:
Disinfection when required according to SOP.




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Bottle: 250-1000 ml
packaging material: HDPE, surlyn/PP
closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP
canister: 5-30 litre
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 litre
packaging material: EVA
closure material: PP/Silicone/EVA
drum: 200 - 220 litre
packaging material: HDPE
closure material is either: PP
IBC: 900-1000 litre
packaging material: HDPE with steel frame closure material is either: PP, HDPE




4.4.1.   Use-specific instructions for use

Spray or pour ready-to-use product on the surface and wipe afterwards or wet a wipe with the ready-to-use product by spraying or pouring and thereafter wipe the surface. Allow to take effect for at least 5 minutes at room temperature (20± 2°C).
4.4.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
4.4.3.   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.
4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

4.4.5.   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.
5.   GENERAL DIRECTIONS FOR USE (3)
OF THE META SPC 3

5.1.   Instructions for use

Clean the surface carefully before use.
Remove excess water from the surface before disinfection, if appropriate.
Do not apply more than 25 ml/m2.
Make sure to wet surfaces completely.
Used wipes must be disposed in a closed container.
5.2.   Risk mitigation measures

The product must only be applied for disinfection of small surfaces.
Ensure adequate ventilation to prevent the formation of explosive atmospheres.
Avoid contact with eyes.
Apply a funnel for refilling.
Keep out of reach of children and pets.
Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:
In case of accident: Call a poison centre or a doctor.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
If on skin: Wash with water. If skin irritation occurs: Get medical advice.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
5.4.   Instructions for safe disposal of the product and its packaging

-
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 36 months
Keep container tightly closed.
Store in a well-ventilated place.
Protect from sunlight.
Store at room temperature in the original container.
6.   OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
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)


mikrozid® classic liquid


Market area: EU




 


mikrozid® IPA liquid


Market area: EU




Surface Disinfection liquid pure


Market area: EU




Authorisation number


EU-0023656-0003 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,1





META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier







Identifier


meta SPC 4 mikrozid wipes




1.2.   Suffix to the authorisation number







Number


1-4




1.3.   Product type(s)







Product type(s)


PT04 - Food and feed area (Disinfectants)
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (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-2-ol


 


Active Substance


67-63-0


200-661-7


63,1


63,1




2.2.   Type(s) of formulation of the meta SPC 4







Formulation(s)


Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4







Hazard statements


Highly flammable liquid and vapour.
Causes serious eye irritation.
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.
Ground and bond container and receiving equipment.
Use explosion-proof electrical/ventilating/lighting equipment.
Use non-sparking tools.
Take action to prevent static discharges.
Avoid breathing vapours.
Avoid breathing spray.
Use only outdoors or in a well-ventilated area.
Wear eye protection.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Call a POISON CENTER or doctor if you feel unwell.
If eye irritation persists:Get medical advice.
If eye irritation persists:Get medical attention.
In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of contents to /container to an approved waste disposal plant.




4.   AUTHORISED USE(S) OF THE META SPC 4

4.1.   Use description



Table 11



Use # 1 – Disinfection of surfaces - wiping







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


-




Target organism(s) (including development stage)


Scientific name: Bacteria including Mycobacterium tuberculosis
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: viruses (limited spectrum virucidal activity)
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas




Application method(s)


Method: Wiping
Detailed description:
Product will be wiped directly on the surface.




Application rate(s) and frequency


Application Rate: Ready-to-use wipes
Dilution (%): -
Number and timing of application:
Disinfection when required according to SOP.




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Soft pack: 1-200 wipes
Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
Pouch: 10-200 wipes
Packaging material: LDPE/PET
Tube: 50-200 wipes
Packaging material: HDPE﻿
closure material is either PP, PE3385




4.1.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect at 20 ± 2°C for at least 5 minutes (bactericidal, yeasticidal and limited spectrum virucidal activity).
4.1.2.   Use-specific risk mitigation measures

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

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.
4.2.   Use description



Table 12



Use # 2 – Disinfection of surfaces with food and feed contact - wiping







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria including Mycobacterium tuberculosis
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Viruses
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of clean non-porous surfaces in kitchens and food industry




Application method(s)


Method: Wiping
Detailed description:
Product will be wiped directly on the surface.




Application rate(s) and frequency


Application Rate: Ready-to-use wipes
Dilution (%): -
Number and timing of application:
Disinfection when required according to SOP.




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Soft pack: 1-200 wipes
Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
Pouch: 10-200 wipes
Packaging material: LDPE/PET
Tube: 50-200 wipes
Packaging material: HDPE
closure material is either PP, PE3385




4.2.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).
4.2.2.   Use-specific risk mitigation measures

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

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

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

5.1.   Instructions for use

Clean the surface carefully before use.
Remove excess water from the surface before disinfection, if appropriate.
Make sure to wet surfaces completely.
Used wipes must be disposed in a closed container.
5.2.   Risk mitigation measures

The product must only be applied for disinfection of small surfaces.
Ensure adequate ventilation to prevent the formation of explosive atmospheres.
Avoid contact with eyes.
Keep out of reach of children and pets.
Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:
In case of accident: Call a poison centre or a doctor.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
If on skin: Wash with water. If skin irritation occurs: Get medical advice.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
5.4.   Instructions for safe disposal of the product and its packaging

-
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage


Shelf-life: 24 months

Keep container tightly closed.
Store in a well-ventilated place.
Protect from sunlight.
Store at room temperature in the original container.
6.   OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
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)


mikrozid® classic wipes


Market area: EU




 


mikrozid® IPA wipes


Market area: EU




surface disinfection wipes classic


Market area: EU




Authorisation number


EU-0023656-0004 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,1





META SPC 5

1.   META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier







Identifier


meta SPC 5 kodan wipes IPA pro




1.2.   Suffix to the authorisation number







Number


1-5




1.3.   Product type(s)







Product type(s)


PT04 - Food and feed area (Disinfectants)
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (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-2-ol


 


Active Substance


67-63-0


200-661-7


63,1


63,1




2.2.   Type(s) of formulation of the meta SPC 5







Formulation(s)


Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5







Hazard statements


Highly flammable liquid and vapour.
Causes serious eye irritation.
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.
Ground and bond container and receiving equipment.
Use explosion-proof electrical/ventilating/lighting equipment.
Use non-sparking tools.
Take action to prevent static discharges.
Avoid breathing vapours.
Avoid breathing spray.
Use only outdoors or in a well-ventilated area.
Wear eye protection.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Call a POISON CENTER or doctor if you feel unwell.
If eye irritation persists:Get medical advice.
If eye irritation persists:Get medical attention.
In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of contents to /container to an approved waste disposal plant.




4.   AUTHORISED USE(S) OF THE META SPC 5

4.1.   Use description



Table 13



Use # 1 – Disinfection of surfaces - wiping







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


-




Target organism(s) (including development stage)


Scientific name: Bacteria including Mycobacterium tuberculosis
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: viruses (limited spectrum virucidal activity)
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas




Application method(s)


Method: Wiping
Detailed description:
Product will be wiped directly on the surface.




Application rate(s) and frequency


Application Rate: Ready-to-use wipes
Dilution (%): -
Number and timing of application:
-




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Soft pack: 1-200 wipes
Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
Pouch: 10-200 wipes
Packaging material: LDPE/PET
Tube: 50-200 wipes
Packaging material: HDPE﻿
closure material is either PP, PE3385




4.1.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect at 20 ± 2°C for at least 5 minutes (bactericidal, yeasticidal and limited spectrum virucidal activity).
4.1.2.   Use-specific risk mitigation measures

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

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.
4.2.   Use description



Table 14



Use # 2 – Disinfection of surfaces with food and feed contact - wiping







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria including Mycobacterium tuberculosis
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Viruses
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of clean non-porous surfaces in kitchens and food industry




Application method(s)


Method: Wiping
Detailed description:
Product will be wiped directly on the surface.




Application rate(s) and frequency


Application Rate: Ready-to-use wipes
Dilution (%): -
Number and timing of application:
-




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Soft pack: 1-200 wipes
Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
Pouch: 10-200 wipes
Packaging material: LDPE/PET
Tube: 50-200 wipes
Packaging material: HDPE
closure material is either PP, PE3385




4.2.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).
4.2.2.   Use-specific risk mitigation measures

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

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

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

5.1.   Instructions for use

Clean the surface carefully before use.
Remove excess water from the surface before disinfection, if appropriate.
Make sure to wet surfaces completely.
Used wipes must be disposed in a closed container.
5.2.   Risk mitigation measures

The product must only be applied for disinfection of small surfaces.
Ensure adequate ventilation to prevent the formation of explosive atmospheres.
Avoid contact with eyes.
Keep out of reach of children and pets.
Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:
In case of accident: Call a poison centre or a doctor.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
If on skin: Wash with water. If skin irritation occurs: Get medical advice.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
5.4.   Instructions for safe disposal of the product and its packaging

-
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months
Keep container tightly closed.
Store in a well-ventilated place.
Protect from sunlight.
Store at room temperature in the original container.
6.   OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
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)


kodan® wipes pure


Market area: EU




 


schülke® classic wipes


Market area: EU




Authorisation number


EU-0023656-0005 1-5




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,1





META SPC 6

1.   META SPC 6 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 6 identifier







Identifier


meta SPC 6 kodan wipes IPA




1.2.   Suffix to the authorisation number







Number


1-6




1.3.   Product type(s)







Product type(s)


PT04 - Food and feed area (Disinfectants)
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (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-2-ol


 


Active Substance


67-63-0


200-661-7


63,1


63,1




2.2.   Type(s) of formulation of the meta SPC 6







Formulation(s)


Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6







Hazard statements


Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.




Precautionary statements


If medical advice is needed, have product container or label at hand.
Keep out of reach of children.
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.
Keep container tightly closed.
Ground and bond container and receiving equipment.
Use explosion-proof electrical/ventilating/lighting equipment.
Use non-sparking tools.
Take action to prevent static discharges.
Avoid breathing vapours.
Avoid breathing spray.
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.
Call a POISON CENTER or doctor if you feel unwell.
If eye irritation persists:Get medical advice.
If eye irritation persists:Get medical attention.
In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of contents to /container to an approved waste disposal plant.




4.   AUTHORISED USE(S) OF THE META SPC 6

4.1.   Use description



Table 15



Use # 1 – Disinfection of surfaces - wiping







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


-




Target organism(s) (including development stage)


Scientific name: Bacteria including Mycobacterium tuberculosis
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: viruses (limited spectrum virucidal activity)
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas




Application method(s)


Method: Wiping
Detailed description:
Product will be wiped directly on the surface.




Application rate(s) and frequency


Application Rate: Ready-to-use wipes
Dilution (%): -
Number and timing of application:
-




Category(ies) of users


Industrial
Professional
General public (non-professional)




Pack sizes and packaging material


Soft pack: 1-200 wipes
Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
Pouch: 10-200 wipes
Packaging material: LDPE/PET
Tube: 50-200 wipes
Packaging material: HDPE﻿
closure material is either PP, PE3385




4.1.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect at 20 ± 2°C for at least 5 minutes (bactericidal, yeasticidal and limited spectrum virucidal activity).
4.1.2.   Use-specific risk mitigation measures

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

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.
4.2.   Use description



Table 16



Use # 2 – Disinfection of surfaces with food and feed contact - wiping







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria including Mycobacterium tuberculosis
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Viruses
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of clean non-porous surfaces in kitchens and food industry




Application method(s)


Method: Wiping
Detailed description:
Product will be wiped directly on the surface.




Application rate(s) and frequency


Application Rate: Ready-to-use wipes
Dilution (%): -
Number and timing of application:
-




Category(ies) of users


Industrial
Professional
General public (non-professional)




Pack sizes and packaging material


Soft pack: 1-200 wipes
Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
Pouch: 10-200 wipes
Packaging material: LDPE/PET
Tube: 50-200 wipes
Packaging material: HDPE
closure material is either PP, PE3385




4.2.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).
4.2.2.   Use-specific risk mitigation measures

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

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

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

5.1.   Instructions for use

Clean the surface carefully before use.
Remove excess water from the surface before disinfection, if appropriate.
Make sure to wet surfaces completely.
Used wipes must be disposed in a closed container.
5.2.   Risk mitigation measures

The product must only be applied for disinfection of small surfaces.
Ensure adequate ventilation to prevent the formation of explosive atmospheres.
Avoid contact with eyes.
Keep out of the reach of children and pets.
Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:
In case of accident: Call a poison centre or a doctor.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
If on skin: Wash with water. If skin irritation occurs: Get medical advice.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
5.4.   Instructions for safe disposal of the product and its packaging

-
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months
Keep container tightly closed.
Store in a well-ventilated place.
Protect from sunlight.
Store at room temperature in the original container.
6.   OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
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)


schülke Hygiene-Tücher


Market area: EU




 


SOS Desinfizierende Feuchttücher


Market area: EU




SOS Hygiene-Tücher


Market area: EU




kodan® clean comfort wipes


Market area: EU




schülke clean comfort wipes


Market area: EU




Hygiene-Tücher


Market area: EU




Desinfizierende Feuchttücher


Market area: EU




Desinfektionstücher


Market area: EU




clean comfort wipes


Market area: EU




disinfecting wipes


Market area: EU




Authorisation number


EU-0023656-0006 1-6




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,1





META SPC 7

1.   META SPC 7 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 7 identifier







Identifier


meta SPC 7 AntiLy SD




1.2.   Suffix to the authorisation number







Number


1-7




1.3.   Product type(s)







Product type(s)


PT04 - Food and feed area (Disinfectants)
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (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-2-ol


 


Active Substance


67-63-0


200-661-7


63,1


63,1




2.2.   Type(s) of formulation of the meta SPC 7







Formulation(s)


Any other liquid (AL), ready-to-use




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7







Hazard statements


Highly flammable liquid and vapour.
Causes serious eye irritation.
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.
Ground and bond container and receiving equipment.
Use explosion-proof electrical/ventilating/lighting equipment.
Use non-sparking tools.
Take action to prevent static discharges.
Avoid breathing vapours.
Avoid breathing spray.
Use only outdoors or in a well-ventilated area.
Wear eye protection.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Call a POISON CENTER or doctor if you feel unwell.
If eye irritation persists:Get medical advice.
If eye irritation persists:Get medical attention.
In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of contents to /container to an approved waste disposal plant.




4.   AUTHORISED USE(S) OF THE META SPC 7

4.1.   Use description



Table 17



Use # 1 – Disinfection of surfaces - spraying







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


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)




Application method(s)


Method: Spraying
Detailed description:
Product will be sprayed directly on the surface.




Application rate(s) and frequency


Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.
Dilution (%): -
Number and timing of application:
-




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Bottle: 125-1000 ml
packaging material: HDPE
Clack cap material: PP; Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel); Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)




4.1.1.   Use-specific instructions for use

Spray ready-to-use product onto the surfaces and allow to take effect for at least 1 minute at room temperature (20±2 °C).
4.1.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.
4.2.   Use description



Table 18



Use # 2 – Disinfection of surfaces - wiping







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


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)




Application method(s)


Method: Wiping
Detailed description:
Product is applied on wipes by pouring, spraying or soaking and the surface is thoroughly wiped with the soaked wipe afterwards (wet-wiping).




Application rate(s) and frequency


Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.
Dilution (%): -
Number and timing of application:
-




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Bottle: 125-1000 ml
packaging material: HDPE
Clack cap material: PP
Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel);
Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)
Canister: 5-30 litre
packaging material: HDPE
closure material: HDPE




4.2.1.   Use-specific instructions for use

Apply the ready-to-use product on wipes by pouring, spraying or soaking and wipe the surface thoroughly with the wet wipe (wet-wiping). Allow to take effect for at least 5 minutes at room temperature (20±2 °C).
4.2.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
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.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.
4.3.   Use description



Table 19



Use # 3 – Disinfection of surfaces with food and feed contact - spraying







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Viruses
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)




Application method(s)


Method: Spraying
Detailed description:
Product will be sprayed directly on the surface.




Application rate(s) and frequency


Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.
Dilution (%): -
Number and timing of application:
-




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Bottle: 125-1000 ml
packaging material: HDPE
Clack cap material: PP
Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)




4.3.1.   Use-specific instructions for use

Spray ready-to-use product onto the surface and allow to take effect at room temperature (20 ± 2 °C) for at least 1 (bactericidal and yeasticidal activity) or 2 minutes (virucidal activity).
4.3.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
4.3.3.   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.
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

4.3.5.   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.
4.4.   Use description



Table 20



Use # 4 – Disinfection of surfaces with food and feed contact - wiping







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Viruses
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)




Application method(s)


Method: Wiping
Detailed description:
Product is applied on wipes by pouring, spraying or soaking and the surface is thoroughly wiped with the soaked wipe afterwards (wet-wiping).




Application rate(s) and frequency


Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.
Dilution (%): -
Number and timing of application:
-




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Bottle: 125-1000 ml
packaging material: HDPE
Clack cap material: PP
Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)
Canister: 5-30 litre
packaging material: HDPE
closure material: HDPE




4.4.1.   Use-specific instructions for use

Apply the ready-to-use product on wipes by pouring, spraying or soaking and wipe the surface thoroughly with the wet wipe (wet-wiping). Allow to take effect for at least 5 minutes at room temperature (20 ±2°C).
4.4.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
4.4.3.   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.
4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

4.4.5.   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.
5.   GENERAL DIRECTIONS FOR USE (7)
OF THE META SPC 7

5.1.   Instructions for use

Clean the surface carefully before use.
Remove excess water from the surface before disinfection, if appropriate.
Do not apply more than 25 ml/m2.
Make sure to wet surfaces completely.
Used wipes must be disposed in a closed container.
5.2.   Risk mitigation measures

The product must only be applied for disinfection of small surfaces.
Ensure adequate ventilation to prevent the formation of explosive atmospheres.
Avoid contact with eyes.
Apply a funnel for refilling.
Keep out of reach of children and pets.
Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:
In case of accident: Call a poison centre or a doctor.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
If on skin: Wash with water. If skin irritation occurs: Get medical advice.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
5.4.   Instructions for safe disposal of the product and its packaging

-
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 36 months
Keep container tightly closed.
Store in a well-ventilated place.
Protect from sunlight.
Store at room temperature in the original container.
6.   OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
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)


AntiLy 5


Market area: EU




Authorisation number


EU-0023656-0007 1-7




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,1




7.2.   Trade name(s), authorisation number and specific composition of each individual product












Trade name(s)


AntiLy 6


Market area: EU




Authorisation number


EU-0023656-0008 1-7




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,1





META SPC 8

1.   META SPC 8 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 8 identifier







Identifier


meta SPC 8 AntiLy SD wipes




1.2.   Suffix to the authorisation number







Number


1-8




1.3.   Product type(s)







Product type(s)


PT04 - Food and feed area (Disinfectants)
PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (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-2-ol


 


Active Substance


67-63-0


200-661-7


63,1


63,1




2.2.   Type(s) of formulation of the meta SPC 8







Formulation(s)


Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8







Hazard statements


Highly flammable liquid and vapour.
Causes serious eye irritation.
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.
Ground and bond container and receiving equipment.
Use explosion-proof electrical/ventilating/lighting equipment.
Use non-sparking tools.
Take action to prevent static discharges.
Avoid breathing vapours.
Avoid breathing spray.
Use only outdoors or in a well-ventilated area.
Wear eye protection.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Call a POISON CENTER or doctor if you feel unwell.
If eye irritation persists:Get medical advice.
If eye irritation persists:Get medical attention.
In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of contents to /container to an approved waste disposal plant.




4.   AUTHORISED USE(S) OF THE META SPC 8

4.1.   Use description



Table 21



Use # 1 – Disinfection of surfaces - wiping







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


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)




Application method(s)


Method: Wiping
Detailed description:
Product will be wiped directly on the surface.




Application rate(s) and frequency


Application Rate: Ready-to-use wipes
Dilution (%): -
Number and timing of application:
-




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Can: 100-150 wipes
Packaging: HDPE
Closure material: HDPE
Pack: 100-150 wipes
Packaging: PET/PE




4.1.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).
4.1.2.   Use-specific risk mitigation measures

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

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.
4.2.   Use description



Table 22



Use # 2 – Disinfection of surfaces with food and feed contact - wiping







Product type


PT04 - Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Viruses
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)




Application method(s)


Method: Wiping
Detailed description:
Product will be wiped directly on the surface.




Application rate(s) and frequency


Application Rate: Ready-to-use wipes
Dilution (%): -
Number and timing of application:
-




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Can: 100-150 wipes
Packaging: HDPE
Closure material: HDPE
Pack: 100-150 wipes
Packaging: PET/PE




4.2.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).
4.2.2.   Use-specific risk mitigation measures

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

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

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

5.1.   Instructions for use

Clean the surface carefully before use.
Remove excess water from the surface before disinfection, if appropriate.
Make sure to wet surfaces completely.
Used wipes must be disposed in a closed container.
5.2.   Risk mitigation measures

The product must only be applied for disinfection of small surfaces.
Ensure adequate ventilation to prevent the formation of explosive atmospheres.
Avoid contact with eyes.
Keep out of reach of children and pets.
Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:
In case of accident: Call a poison centre or a doctor.
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
If on skin: Wash with water. If skin irritation occurs: Get medical advice.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
5.4.   Instructions for safe disposal of the product and its packaging

-
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months
Keep container tightly closed.
Store in a well-ventilated place.
Protect from sunlight.
Store at room temperature in the original container.
6.   OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
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)


AntiLy 5 wipes


Market area: EU




Authorisation number


EU-0023656-0009 1-8




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,1




7.2.   Trade name(s), authorisation number and specific composition of each individual product












Trade name(s)


AntiLy 6 wipes


Market area: EU




Authorisation number


EU-0023656-0010 1-8




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,1






(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.



ELI: http://data.europa.eu/eli/reg_impl/2024/2194/oj
ISSN 1977-0677 (electronic edition)