Commission Implementing Regulation (EU) 2021/978 of 10 June 2021 granting a Union authorisation for the biocidal product family “Lyso IPA Surface Disinfection” (Text with EEA relevance)
Date: 2021-06-10
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, decontamination, market approval








L_2021216EN.01006501.xml










18.6.2021   


EN


Official Journal of the European Union


L 216/65








            COMMISSION IMPLEMENTING REGULATION (EU) 2021/978
of 10 June 2021
         
granting a Union authorisation for the biocidal product family “Lyso IPA Surface Disinfection”
         
(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 the first subparagraph of Article 44(5) thereof,

Whereas:







(1)


On 22 June 2016, Schuelke & Mayr GmbH submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for authorisation of the same biocidal product family, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named “Lyso IPA Surface Disinfection”, of product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-GX025200-35 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference product family “perform-IPA”, recorded in the Register under case number BC-AB023095-72.












(2)


The same biocidal product family “Lyso IPA Surface Disinfection” 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 12 May 2020, the Agency submitted to the Commission an opinion (3) and the draft summary of the biocidal product characteristics (‘SPC’) of “Lyso IPA Surface Disinfection” in accordance with Article 6(1) and (2) of Implementing Regulation (EU) No 414/2013.












(4)


The opinion concludes that “Lyso IPA Surface Disinfection” is a biocidal product family within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, that the proposed differences between the same biocidal product family and the related reference biocidal product family are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (4), that “Lyso IPA Surface Disinfection” is eligible for Union authorisation in accordance with Article 42(1) of Regulation (EU) No 528/2012, and that based on the assessment of the related reference “perform-IPA” product family and subject to compliance with the draft SPC, the same biocidal product family meets the conditions laid down in Article 19(1) and (6) of Regulation (EU) No 528/2012.












(5)


On 6 November 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.












(6)


The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same biocidal product family “Lyso IPA Surface Disinfection”.












(7)


The same biocidal product family “Lyso IPA Surface Disinfection” contains the non-active substance diethyl phthalate, for which 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 (5) within the period for the evaluation of the application for the related reference biocidal product family. 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 “Lyso IPA Surface Disinfection” in accordance with Article 48 of Regulation (EU) No 528/2012.












(8)


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





HAS ADOPTED THIS REGULATION:



Article 1
A Union authorisation with authorisation number EU-0023860-0000 is granted to Schuelke & Mayr GmbH for the making available on the market and use of the same biocidal product family “Lyso IPA Surface Disinfection” in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 8 July 2021 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, 10 June 2021.


For the Commission


The President

Ursula VON DER LEYEN
            





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

(2)  Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4).

(3)  ECHA opinion of 11 May 2020 on the Union authorisation of the same biocidal product family “Lyso IPA Surface Disinfection”, https://echa.europa.eu/en/opinions-on-union-authorisation

(4)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4).

(5)  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
Lyso IPA Surface Disinfection
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-0023860-0000
R4BP asset number: EU-0023860-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name







Name


Lyso IPA Surface Disinfection




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-0023860-0000





R4BP asset number



EU-0023860-0000




Date of the authorisation


8 July 2021




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 Naumbourg (Saale) Germany




Location of manufacturing sites


Am Hohen Stein 11, 06618 Naumbourg (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-SPC1




1.2.   Suffix to the authorisation number







Number


1-1




1.3.   Product type(s)







Product type(s)


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




2.   META SPC 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/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 minute (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)


Schülke® 6


Market area: EU




Authorisation number


EU-0023860-0001 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




1.2.   Suffix to the authorisation number







Number


1-2




1.3.   Product type(s)







Product type(s)


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




2.   META SPC 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
Tub: 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
Tub: 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)


Schülke® 7


Market area: EU




Authorisation number


EU-0023860-0002 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




1.2.   Suffix to the authorisation number







Number


1-3




1.3.   Product type(s)







Product type(s)


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




2.   META SPC 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 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 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 minute (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: 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)


Schülke® 8


Market area: EU




Authorisation number


EU-0023860-0003 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




1.2.   Suffix to the authorisation number







Number


1-4




1.3.   Product type(s)







Product type(s)


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




2.   META SPC 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
Tub: 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 incl. 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
Tub: 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)


Schülke® 9


Market area: EU




Authorisation number


EU-0023860-0004 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




1.2.   Suffix to the authorisation number







Number


1-5




1.3.   Product type(s)







Product type(s)


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




2.   META SPC 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
Tub: 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
Tub: 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)


Schülke® 10


Market area: EU




Authorisation number


EU-0023860-0005 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-SPC6 kodan wipes IPA




1.2.   Suffix to the authorisation number







Number


1-6




1.3.   Product type(s)







Product type(s)


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




2.   META SPC 6 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 6












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Propan-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
Tub: 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
Tub: 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® 11


Market area: EU




Authorisation number


EU-0023860-0006 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-SPC7




1.2.   Suffix to the authorisation number







Number


1-7




1.3.   Product type(s)







Product type(s)


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




2.   META SPC 7 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 7












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Propan-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 minute (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)


Superficid®
Desocid rapid
Neoseptin rapid
Novosept rapid
Novoseptin rapid
Lyorthol rapid
Cosmo rapid
Fordesin rapid
Saltero rapid
Prop70 rapid
Aldovet rapid
Vetfarm rapid
MDI rapid
Antiseptica rapid
Sterisol Surface
MENNO® I-QUICK plus


Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU




Authorisation number


EU-0023860-0007 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)


Superficid® pure
Desocid rapid pure
Neoseptin rapid pure
Novosept rapid pure
Novoseptin rapid pure
Lyorthol rapid pure
Cosmo rapid pure
Fordesin rapid pure
Saltero rapid pure
Prop70 rapid pure
Aldovet rapid pure
Vetfarm rapid pure
MDI rapid pure
Antiseptica rapid pure
Sterisol Surface pure
BTS 6000
MENNO® I-QUICK
EWA® DES ready
Kiehl-Rapinol
Des A


Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU




Authorisation number


EU-0023860-0008 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-SPC8




1.2.   Suffix to the authorisation number







Number


1-8




1.3.   Product type(s)







Product type(s)


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




2.   META SPC 8 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 8












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Propan-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)


Descorapid® Tücher
Desocid Tücher
Neoseptin Tücher
Novosept Tücher
Novoseptin Tücher
Lyorthol Tücher
Cosmo Tücher
Fordesin Tücher
Saltero Tücher
Prop70 Tücher
Manosafe Tücher
Dermoguard Tücher
Dermosafe Tücher
Aldovet Tücher
Vetfarm Tücher
MDI Tücher
Antiseptica Tücher
Antiseptica wipes
MENNO®WIP
Descorapid® wipes
Desocid wipes
Neoseptin wipes
Novosept wipes
Novoseptin wipes
Lyorthol wipes
Cosmo wipes
Fordesin wipes
Saltero wipes
Prop70 wipes
Manosafe wipes
Dermoguard wipes
Dermosafe wipes
Aldovet wipes
Vetfarm wipes
MDI wipes


Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU




Authorisation number


EU-0023860-0009 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)


Superficid® pure wipes
Desocid rapid pure wipes
Neoseptin rapid pure wipes
Novosept rapid pure wipes
Novoseptin rapid pure wipes
Lyorthol rapid pure wipes
Cosmo rapid pure wipes
Fordesin rapid pure wipes
Saltero rapid pure wipes
Prop70 rapid pure wipes
Aldovet rapid pure wipes
Vetfarm rapid pure wipes
MDI rapid pure wipes
Antiseptica rapid pure wipes


Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU
Market area: EU




Authorisation number


EU-0023860-0010 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.