Commission Implementing Regulation (EU) 2020/1991 of 27 November 2020 granting a Union authorisation for the biocidal product family ‘perform-IPA’ (Text with EEA relevance)
Date: 2020-11-27
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal health, biocide, chemical product, decontamination, food safety, health control, market approval








L_2020410EN.01000101.xml










7.12.2020   


EN


Official Journal of the European Union


L 410/1








            COMMISSION IMPLEMENTING REGULATION (EU) 2020/1991
of 27 November 2020
         
granting a 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 44(5) thereof,

Whereas:







(1)


On 19 April 2016, Schuelke & Mayr GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘perform-IPA’ of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Germany had agreed to evaluate the application. The application was recorded under case number BC-AB023095-72 in the Register for Biocidal Products.












(2)


‘perform-IPA’ contains propan-2-ol, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012.












(3)


On 27 August 2019, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).












(4)


On 7 April 2020, the Agency submitted to the Commission an opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘perform-IPA’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.












(5)


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












(6)


On 27 April 2020, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.












(7)


The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘perform-IPA’.












(8)


According to the opinion of the Agency, as regards the non-active substance diethyl phthalate contained in ‘perform-IPA’, it was not possible to conclude whether it meets the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100 (3) within the period for the evaluation of the application. Further examination of diethyl phthalate should therefore take place. If it is concluded that diethyl phthalate is considered as having endocrine-disrupting properties, the Commission will consider whether to cancel or amend the Union authorisation for ‘perform-IPA’ in accordance with Article 48 of Regulation (EU) No 528/2012.












(9)


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





HAS ADOPTED THIS REGULATION:



Article 1
A Union authorisation with authorisation number EU-0023656-0000 is granted to Schuelke & Mayr GmbH for the making available on the market and use of the biocidal product family ‘perform-IPA’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 27 December 2020 until 30 November 2030.


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, 27 November 2020.


For the Commission


The President

Ursula VON DER LEYEN
            





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

(2)  ECHA opinion of 5 March 2020 on the Union authorisation of ‘perform-IPA’ (ECHA/BPC/245/2020), https://echa.europa.eu/bpc-opinions-on-union-authorisation

(3)  Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1).




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


Schülke & 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


Boschstr. 5, 63768 Hösbach Germany




Location of manufacturing sites


Boschstr. 5, 63768 Hösbach Germany
Neue Straße 2-4, 09471 Köningswalde Germany













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


Am Hohen Stein 11, 06618 Naumburg (Saale) Germany




Location of manufacturing sites


Am Hohen Stein 11, 06618 Naumburg (Saale) Germany













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




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: -




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)


Spraying
Product will be sprayed directly on the surface




Application rate(s) and frequency


Ready-to-use. Do not apply more than 25 ml/m2.
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: 5-10 L
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 L
packaging material: EVA
closure material: PP/Silicone/EVA




4.1.1.   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 minute.
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: -




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)


Wiping
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


Ready-to-use. Do not apply more than 25 ml/m2.
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: 5-10 L
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 L
packaging material: EVA
closure material: PP/Silicone/EVA.




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 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 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 including cleanrooms (class A/B)




Application method(s)


Spraying
Product will be sprayed directly on the surface.




Application rate(s) and frequency


Ready-to-use. Do not apply more than 25 ml/m2.
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: 5-10 L
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 L
packaging material: EVA
closure material: PP/Silicone/EVA.




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 including cleanrooms (class A/B)




Application method(s)


Wiping
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


Ready-to-use. Do not apply more than 25 ml/m2.
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: 5-10 L
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 L
packaging material: EVA
closure material: PP/Silicone/EVA.




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
perform® classic alcohol IPA
buraton® IPA
perform® advanced alcohol IPA
arcana® IPA
clear IPA
pure IPA
disinfectant IPA
Surface disinfection liquid classic
sterile IPA
mikrozid® sterile liquid
Surface disinfection liquid sterile
BTS 6000




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 /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: -




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)


Wiping
Product will be wiped directly on the surface.




Application rate(s) and frequency


Ready-to-use wipes
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 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 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 including cleanrooms (class A/B)




Application method(s)


Wiping
Product will be wiped directly on the surface.




Application rate(s) and frequency


Ready-to-use wipes
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
buraton® wipes IPA
perform® advanced wipes IPA
arcana® wipes IPA
clear IPA wipes
pure IPA wipes
disinfectant IPA wipes
Surface disinfection wipes classic
perform® sterile wipes IPA
sterile IPA wipes
mikrozid® sterile wipes
Surface disinfection wipes sterile




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 /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: -




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)


Spraying
Product will be sprayed directly on the surface




Application rate(s) and frequency


Ready-to-use. Do not apply more than 25 ml/m2.
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: 5-10 L
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 L
packaging material: EVA
Closure : PP/Silicone/EVA




4.1.1.   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 minute.
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: -




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)


Wiping
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


Ready-to-use. Do not apply more than 25 ml/m2.
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: 5-10 L
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 L
packaging material: EVA
Closure : PP/Silicone/EVA




4.2.1.   Use-specific instructions for use

Spray or pour rready-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).
4.2.2.   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 including cleanrooms (class A/B)




Application method(s)


Spraying
Product will be sprayed directly on the surface.




Application rate(s) and frequency


Ready-to-use. Do not apply more than 25 ml/m2.
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: 5-10 L
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 L
packaging material: EVA
Closure : PP/Silicone/EVA




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 including cleanrooms (class A/B)




Application method(s)


Wiping
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


Ready-to-use. Do not apply more than 25 ml/m2.
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: 5-10 L
packaging material: HDPE.
closure material is either: HDPE/LDPE
Revolver BAG: 1 L
packaging material: EVA
closure material: PP/Silicone/EVA




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
mikrozid® IPA liquid
Surface Disinfection liquid pure




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 /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: -




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)


Wiping
Product will be wiped directly on the surface.




Application rate(s) and frequency


Ready-to-use wipes
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 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 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 including cleanrooms (class A/B)




Application method(s)


Wiping
Product will be wiped directly on the surface.




Application rate(s) and frequency


Ready-to-use wipes
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
mikrozid® IPA wipes
surface disinfection wipes classic




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 /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: -




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)


Wiping
Product will be wiped directly on the surface.




Application rate(s) and frequency


Ready-to-use wipes




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 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 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 including cleanrooms (class A/B)




Application method(s)


Wiping
Product will be wiped directly on the surface.




Application rate(s) and frequency


Ready-to-use wipes




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
schülke® classic wipes




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 /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: -




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)


Wiping
Product will be wiped directly on the surface.




Application rate(s) and frequency


Ready-to-use wipes




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 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 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 including cleanrooms (class A/B)




Application method(s)


Wiping
Product will be wiped directly on the surface.




Application rate(s) and frequency


Ready-to-use wipes




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
SOS Desinfizierende Feuchttücher
SOS Hygiene-Tücher
kodan® clean comfort wipes
schülke clean comfort wipes
Hygiene-Tücher
Desinfizierende Feuchttücher
Desinfektionstücher
clean comfort wipes
disinfecting wipes




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 /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)


Spraying
Product will be sprayed directly on the surface.




Application rate(s) and frequency


Ready-to-use. Do not apply more than 25 ml/m2.




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)


Wiping
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


Ready-to-use. Do not apply more than 25 ml/m2.




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 L
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)


Spraying
Product will be sprayed directly on the surface.




Application rate(s) and frequency


Ready-to-use. Do not apply more than 25 ml/m2.




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)


Wiping
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


Ready-to-use. Do not apply more than 25 ml/m2.




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 L
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




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




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 /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)


Wiping
Product will be wiped directly on the surface.




Application rate(s) and frequency


Ready-to-use wipes




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)


Wiping
Product will be wiped directly on the surface.




Application rate(s) and frequency


Ready-to-use wipes




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




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




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.