Commission Implementing Regulation (EU) 2023/2087 of 28 September 2023 granting a Union authorisation for the biocidal product family ‘Lysoform IPA Surface’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
Date: 2023-09-28
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, biocide, chemical product, decontamination, food safety, market approval, pharmaceutical product








L_2023241EN.01007801.xml










29.9.2023   


EN


Official Journal of the European Union


L 241/78








            COMMISSION IMPLEMENTING REGULATION (EU) 2023/2087
of 28 September 2023
         
granting a Union authorisation for the biocidal product family ‘Lysoform IPA Surface’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

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


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

Whereas:







(1)


On 25 November 2022, Lysoform Dr Hans Rosemann 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 a same biocidal product family, as referred to in Article 1 of that Regulation, named ‘Lysoform IPA Surface’, for product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-DP082158-26 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference biocidal product family ‘Lyso IPA Surface Disinfection’, recorded in the Register under case number BC-GX025200-35.












(2)


The same biocidal product family ‘Lysoform IPA Surface’ contains propan-2-ol as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 4.












(3)


On 31 March 2023, the Agency submitted to the Commission its opinion (3) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Lysoform IPA Surface’ in accordance with Article 6 of Implementing Regulation (EU) No 414/2013.












(4)


The opinion concludes 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), and that based on the assessment of the related reference biocidal product family ‘Lyso IPA Surface Disinfection’ 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 31 March 2023, 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 ‘Lysoform IPA Surface’.












(7)


The expiry date of this authorisation is aligned to the expiry date of the reference biocidal product family ‘Lyso IPA Surface Disinfection’.












(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-0030790-0000 is hereby granted to Lysoform Dr Hans Rosemann GmbH for the making available on the market and use of the same biocidal product family ‘Lysoform IPA Surface’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 19 October 2023 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, 28 September 2023.


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 for ‘Lysoform IPA Surface’, 31 March 2023, https://echa.europa.eu/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).




ANNEX
Summary of product characteristics for a biocidal product family
Lysoform IPA Surface
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-0030790-0000
R4BP asset number: EU-0030790-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name







Name


Lysoform IPA Surface




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


Lysoform Dr Hans Rosemann GmbH




Address


Kaiser-Wilhelm-Str. 133, 12247 Berlin Germany




Authorisation number


EU-0030790-0000





R4BP asset number



EU-0030790-0000




Date of the authorisation


19 October 2023




Expiry date of the authorisation


30 November 2030




1.4.   Manufacturer(s) of the biocidal products







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


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


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


Sterisol AB




Address of manufacturer


Kronoängsgatan 3, 592 23 Vadstena Sweden




Location of manufacturing sites


Kronoängsgatan 3, 592 23 Vadstena Sweden













Name of manufacturer


WHR GmbH




Address of manufacturer


Am Galgenturm 2, 97638 Mellrichstadt Germany




Location of manufacturing sites


Am Galgenturm 2, 97638 Mellrichstadt Germany













Name of manufacturer


Hygan GmbH | Srl




Address of manufacturer


Meucci-Str. 5, 39055 Leifers | Laives (BZ) Italy




Location of manufacturing sites


Meucci-Str. 5, 39055 Leifers | Laives (BZ) Italy













Name of manufacturer


Laboratoire Sarbec SA




Address of manufacturer


10 rue du Vertuquet, 59960 Neuville-en-Ferrain France




Location of manufacturing sites


10 rue du Vertuquet, 59960 Neuville-en-Ferrain France













Name of manufacturer


Dr Schumacher GmbH




Address of manufacturer


Am Roggenfeld 3, 34323 Malsfeld Germany




Location of manufacturing sites


Am Roggenfeld 3, 34323 Malsfeld Germany
Jeleniogórska 12, 59-800 Lubań Poland




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


Superficid®




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 to/container to an approved waste disposal plant.




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

4.1.   Use description


Table 1


Use # 1 disinfection of surfaces – spraying







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


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




Application method(s)


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




Application rate(s) and frequency


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




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Bottle: 125-1 000  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 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)


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




Application rate(s) and frequency


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




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Bottle: 125-1 000  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 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)


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




Application rate(s) and frequency


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




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Bottle: 125-1 000  ml
packaging material: HDPE
Clack cap material: PP
Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)




4.3.1.   Use-specific instructions for use

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

The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

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

See general directions for use.
4.4.   Use description


Table 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)


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




Application rate(s) and frequency


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




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


Bottle: 125-1 000  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 (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)


Superficid®


Market area: EU




 


Desocid rapid


Market area: EU




Neoseptin rapid


Market area: EU




Novosept rapid


Market area: EU




Novoseptin rapid


Market area: EU




Lyorthol rapid


Market area: EU




Cosmo rapid


Market area: EU




Fordesin rapid


Market area: EU




Saltero rapid


Market area: EU




Prop70 rapid


Market area: EU




Aldovet rapid


Market area: EU




Vetfarm rapid


Market area: EU




MDI rapid


Market area: EU




Antiseptica rapid


Market area: EU




Sterisol Surface


Market area: EU




MENNO® I-QUICK plus


Market area: EU




Authorisation number


EU-0030790-0001 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 




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











Trade name(s)


Superficid® pure


Market area: EU




 


Desocid rapid pure


Market area: EU




Neoseptin rapid pure


Market area: EU




Novosept rapid pure


Market area: EU




Novoseptin rapid pure


Market area: EU




Lyorthol rapid pure


Market area: EU




Cosmo rapid pure


Market area: EU




Fordesin rapid pure


Market area: EU




Saltero rapid pure


Market area: EU




Prop70 rapid pure


Market area: EU




Aldovet rapid pure


Market area: EU




Vetfarm rapid pure


Market area: EU




MDI rapid pure


Market area: EU




Antiseptica rapid pure


Market area: EU




Sterisol Surface pure


Market area: EU




BTS 6000


Market area: EU




MENNO® I-QUICK


Market area: EU




EWA® DES ready


Market area: EU




Kiehl-Rapinol


Market area: EU




Des A


Market area: EU




Authorisation number


EU-0030790-0002 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


Descorapid®




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 to/container to an approved waste disposal plant.




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

4.1.   Use description


Table 5


Use # 1 – disinfection of surfaces – wiping







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


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




Field(s) of use


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




Application method(s)


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




Application rate(s) and frequency


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




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


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




4.1.1.   Use-specific instructions for use

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

See general directions for use.
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

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

See general directions for use.
4.2.   Use description


Table 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)


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




Application rate(s) and frequency


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




Category(ies) of users


Industrial
Professional




Pack sizes and packaging material


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




4.2.1.   Use-specific instructions for use

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

See general directions for use.
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

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

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

See general directions for use.
5.   GENERAL DIRECTIONS FOR USE (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)


Descorapid® Tücher


Market area: EU




 


Desocid Tücher


Market area: EU




Neoseptin Tücher


Market area: EU




Novosept Tücher


Market area: EU




Novoseptin Tücher


Market area: EU




Lyorthol Tücher


Market area: EU




Cosmo Tücher


Market area: EU




Fordesin Tücher


Market area: EU




Saltero Tücher


Market area: EU




Prop70 Tücher


Market area: EU




Manosafe Tücher


Market area: EU




Dermoguard Tücher


Market area: EU




Dermosafe Tücher


Market area: EU




Aldovet Tücher


Market area: EU




Vetfarm Tücher


Market area: EU




MDI Tücher


Market area: EU




Antiseptica Tücher


Market area: EU




Antiseptica wipes


Market area: EU




MENNO®WIP


Market area: EU




Descorapid® wipes


Market area: EU




Desocid wipes


Market area: EU




Neoseptin wipes


Market area: EU




Novosept wipes


Market area: EU




Novoseptin wipes


Market area: EU




Lyorthol wipes


Market area: EU




Cosmo wipes


Market area: EU




Fordesin wipes


Market area: EU




Saltero wipes


Market area: EU




Prop70 wipes


Market area: EU




Manosafe wipes


Market area: EU




Dermoguard wipes


Market area: EU




Dermosafe wipes


Market area: EU




Aldovet wipes


Market area: EU




Vetfarm wipes


Market area: EU




MDI wipes


Market area: EU




Antiseptica wipes


Market area: EU




Authorisation number


EU-0030790-0003 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 




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











Trade name(s)


Superficid® pure wipes


Market area: EU




 


Desocid rapid pure wipes


Market area: EU




Neoseptin rapid pure wipes


Market area: EU




Novosept rapid pure wipes


Market area: EU




Novoseptin rapid pure wipes


Market area: EU




Lyorthol rapid pure wipes


Market area: EU




Cosmo rapid pure wipes


Market area: EU




Fordesin rapid pure wipes


Market area: EU




Saltero rapid pure wipes


Market area: EU




Prop70 rapid pure wipes


Market area: EU




Aldovet rapid pure wipes


Market area: EU




Vetfarm rapid pure wipes


Market area: EU




MDI rapid pure wipes


Market area: EU




Antiseptica rapid pure wipes


Market area: EU




Authorisation number


EU-0030790-0004 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 






(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.