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Official Journal
of the European Union

EN

L series


2024/2194

5.9.2024

COMMISSION IMPLEMENTING REGULATION (EU) 2024/2194

of 4 September 2024

amending Implementing Regulation (EU) 2020/1991 as regards administrative and minor changes to the Union authorisation for the biocidal product family ‘perform-IPA’

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 50(2) thereof,

Whereas:

(1)

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

(2)

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

(3)

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

(4)

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

(5)

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

(6)

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

(7)

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

(8)

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

(9)

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

(10)

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

(11)

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

HAS ADOPTED THIS REGULATION:

Article 1

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

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 4 September 2024.

For the Commission

The President

Ursula VON DER LEYEN


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

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

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

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

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


ANNEX

Summary of product characteristics for a biocidal product family

perform-IPA

Product type 2 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Product type 4 - Food and feed area (Disinfectants)

Authorisation number: EU-0023656-0000

R4BP asset number: EU-0023656-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

Name

perform-IPA

1.2.   Product type(s)

Product type(s)

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

PT04 - Food and feed area (Disinfectants)

1.3.   Authorisation holder

Name and address of the authorisation holder

Name

Schuelke & Mayr GmbH

Address

Robert-Koch-Str. 2, 22851 Norderstedt Germany

Authorisation number

EU-0023656-0000

R4BP asset number

EU-0023656-0000

Date of the authorisation

27 December 2020

Expiry date of the authorisation

30 November 2030

1.4.   Manufacturer(s) of the biocidal products

Name of manufacturer

Schülke & Mayr GmbH

Address of manufacturer

Robert-Koch-Str. 2, 22851 Norderstedt Germany

Location of manufacturing sites

Robert-Koch-Str. 2, 22851 Norderstedt Germany


Name of manufacturer

BOCHEMIE a.s.

Address of manufacturer

Lidická 326, 735 95 Bohumín Czech Republic

Location of manufacturing sites

Lidická 326, 735 95 Bohumín Czech Republic


Name of manufacturer

Imeco

Address of manufacturer

Am Sägewerk 10, 63773 Goldbach Germany

Location of manufacturing sites

Boschstr. 5, 63768 Hösbach Germany

Neue Straße 2-4, 09471 Köningswalde Germany

Am Gansberg 9, 09481 Elterlein Germany

ul.Wlo'kiennicza 10, 59-800 Luban Poland


Name of manufacturer

Tristel Solutions Limited

Address of manufacturer

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

Location of manufacturing sites

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


Name of manufacturer

Techtex

Address of manufacturer

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

Location of manufacturing sites

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


Name of manufacturer

A.F.P. GmbH

Address of manufacturer

Otto Brenner Straße 16, 21337 Lüneburg Germany

Location of manufacturing sites

Otto Brenner Straße 16, 21337 Lüneburg Germany


Name of manufacturer

Innovate GmbH

Address of manufacturer

Gewerbegebietsstraße 30, 06618 Schönburg Germany

Location of manufacturing sites

Gewerbegebietsstraße 30, 06618 Schönburg Germany

Keizersveld 99, 5803 AP Venray Netherlands


Name of manufacturer

Lysoform Dr. Hans Rosemann GmbH

Address of manufacturer

Kaiser-Wilhelm-Straße 133, 12247 Berlin Germany

Location of manufacturing sites

Kaiser-Wilhelm-Straße 133, 12247 Berlin Germany


Name of manufacturer

Sterisol AB

Address of manufacturer

Kronoängsgatan 3, 592 23 Vadstena Sweden

Location of manufacturing sites

Kronoängsgatan 3, 592 23 Vadstena Sweden


Name of manufacturer

Rudolf Dankwardt GmbH

Address of manufacturer

Gutenbergring 50-52, 22848 Norderstedt Germany

Location of manufacturing sites

Gutenbergring 50-52, 22848 Norderstedt Germany

Lagerstr. 15, 19249 Jessenitz - Werk / Lübtheen Germany


Name of manufacturer

BIOXAL SA

Address of manufacturer

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

Location of manufacturing sites

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


Name of manufacturer

Lichtenheldt GmbH

Address of manufacturer

Industriestrasse 7-9, 23812 Wahlstedt Germany

Location of manufacturing sites

Industriestrasse 7-9, 23812 Wahlstedt Germany

Justus-Liebig-Weg 1, 23812 Wahlstedt Germany


Name of manufacturer

NATURELLE CONSUMER PRODUCTS LTD

Address of manufacturer

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

Location of manufacturing sites

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


Name of manufacturer

Halag Chemie AG

Address of manufacturer

Weiernstrasse 30, 8355 Aadorf Switzerland

Location of manufacturing sites

Weiernstrasse 30, 8355 Aadorf Switzerland


Name of manufacturer

PDI (EMEA) Ltd

Address of manufacturer

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

Location of manufacturing sites

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

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

Active substance

Propan-2-ol

Name of manufacturer

Ineos Solvents Germany GmbH (formerly Sasol)

Address of manufacturer

Römerstraße 733, 47443 Moers Germany

Location of manufacturing sites

Römerstraße 733, 47443 Moers Germany

Shamrockstr. 88, 44643 Herne Germany


Active substance

Propan-2-ol

Name of manufacturer

Shell Chemicals Europe B.V.

Address of manufacturer

Postbus 2334, 3000 CH Rotterdam Netherlands

Location of manufacturing sites

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

2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

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

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

 

Active Substance

67-63-0

200-661-7

63,1

63,1

2.2.   Type(s) of formulation

Formulation(s)

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

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

PART II

SECOND INFORMATION LEVEL - META SPC(S)

META SPC 1

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier

Identifier

meta SPC 1 perform IPA liquid

1.2.   Suffix to the authorisation number

Number

1-1

1.3.   Product type(s)

Product type(s)

PT04 - Food and feed area (Disinfectants)

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

2.   META SPC 1 COMPOSITION

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

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

 

Active Substance

67-63-0

200-661-7

63,1

63,1

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

Formulation(s)

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

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements

Highly flammable liquid and vapour.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

Keep container tightly closed.

Ground and bond container and receiving equipment.

Use explosion-proof electrical/ventilating/lighting equipment.

Use non-sparking tools.

Take action to prevent static discharges.

Avoid breathing vapours.

Avoid breathing spray.

Use only outdoors or in a well-ventilated area.

Wear eye protection.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Call a POISON CENTER or doctor if you feel unwell.

If eye irritation persists:Get medical advice.

If eye irritation persists:Get medical attention.

In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.

Store in a well-ventilated place.Keep cool.

Store locked up.

Dispose of contents to /container to an approved waste disposal plant.

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

4.1.   Use description

Table 1

Use # 1 – Disinfection of surfaces - spraying

Product type

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

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: viruses (limited spectrum virucidal activity)

Common name: -

Development stage: -

Field(s) of use

Indoor

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

Application method(s)

Method: Spraying

Detailed description:

Product will be sprayed directly on the surface

Application rate(s) and frequency

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

Dilution (%): -

Number and timing of application:

Disinfection after each production and cleaning process or when required according to standard operating procedure (SOP)

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 250-1000 ml

packaging material: high-density polyethylene (HDPE), surlyn/polypropylene (PP)

closure material is either: PP, polyoxymethylene (POM), low-density polyethylene (LDPE), HDPE, polyethylene (PE), ethylene-vinyl acetate (EVA), stainless steel, polybutylene terephthalate (PBT), (LD)PE, exp. polytetrafluoroethylene (PTFE), linear low density polyethylene (LLDPE), expanded PE (EXPPE), Co Polymer PP

canister: 5-30 litre

packaging material: HDPE.

closure material is either: HDPE/LDPE

Revolver BAG: 1 litre

packaging material: EVA

closure material: PP/Silicone/EVA

drum: 200 - 220 litre

packaging material: HDPE

closure material is either: PP

IBC: 900-1000 litre

packaging material: HDPE with steel frame

closure material is either: PP, HDPE

4.1.1.   Use-specific instructions for use

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

4.1.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.

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

See general directions for use.

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

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

See general directions for use.

4.2.   Use description

Table 2

Use # 2 – Disinfection of surfaces - wiping

Product type

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

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: viruses (limited spectrum virucidal activity)

Common name: -

Development stage: -

Field(s) of use

Indoor

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

Application method(s)

Method: Wiping

Detailed description:

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

Application rate(s) and frequency

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

Dilution (%): -

Number and timing of application:

Disinfection after each production and cleaning process or when required according to SOP.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 250-1000 ml

packaging material: HDPE, surlyn/PP

closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP. 

canister: 5-30 litre

packaging material: HDPE.

closure material is either: HDPE/LDPE

Revolver BAG: 1 litre

packaging material: EVA

closure material: PP/Silicone/EVA.

drum: 200 - 220 litre

packaging material: HDPEclosure material is either: PP

IBC: 900-1000 litre

packaging material: HDPE with steel frameclosure material is either: PP, HDPE

4.2.1.   Use-specific instructions for use

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

4.2.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.

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

See general directions for use.

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

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

See general directions for use.

4.3.   Use description

Table 3

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

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

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

Application method(s)

Method: Spraying

Detailed description:

Product will be sprayed directly on the surface.

Application rate(s) and frequency

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

Dilution (%): -

Number and timing of application:

Disinfection after each production and cleaning process or when required according to SOP.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 250-1000 ml

packaging material: HDPE, surlyn/PP

closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP. 

canister: 5-30 litre

packaging material: HDPE.

closure material is either: HDPE/LDPE

Revolver BAG: 1 litre

packaging material: EVA

closure material: PP/Silicone/EVA.

drum: 200 - 220 litre

packaging material: HDPEclosure material is either: PP

IBC: 900-1000 litre

packaging material: HDPE with steel frame

closure material is either: PP, HDPE

4.3.1.   Use-specific instructions for use

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

4.3.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.

4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

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

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

See general directions for use.

4.4.   Use description

Table 4

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

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

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

Application method(s)

Method: Wiping

Detailed description:

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

Application rate(s) and frequency

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

Dilution (%): -

Number and timing of application:

Disinfection after each production and cleaning process or when required according to SOP.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 250-1000 ml

packaging material: HDPE, surlyn/PP

closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP. 

canister: 5-30 litre

packaging material: HDPE.

closure material is either: HDPE/LDPE

Revolver BAG: 1 litre

packaging material: EVA

closure material: PP/Silicone/EVA.

drum: 200 - 220 litre

packaging material: HDPE closure material is either: PP

IBC: 900-1000 litre

packaging material: HDPE with steel frame closure material is either: PP, HDPE

4.4.1.   Use-specific instructions for use

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

4.4.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.

4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

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

See general directions for use.

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

5.1.   Instructions for use

Clean the surface carefully before use.

Remove excess water from the surface before disinfection, if appropriate.

Do not apply more than 25 ml/m2.

Make sure to wet surfaces completely.

Used wipes must be disposed in a closed container.

5.2.   Risk mitigation measures

The product must only be applied for disinfection of small surfaces.

Ensure adequate ventilation to prevent the formation of explosive atmospheres.

Avoid contact with eyes.

Apply a funnel for refilling.

Keep out of reach of children and pets.

Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:

In case of accident: Call a poison centre or a doctor.

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

If on skin: Wash with water. If skin irritation occurs: Get medical advice.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.

5.4.   Instructions for safe disposal of the product and its packaging

-

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

Shelf-life: 36 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

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

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1

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

Trade name(s)

perform® sterile alcohol IPA

Market area: EU

 

perform® classic alcohol IPA

Market area: EU

buraton® IPA

Market area: EU

perform® advanced alcohol IPA

Market area: EU

arcana® IPA

Market area: EU

clear IPA

Market area: EU

pure IPA

Market area: EU

disinfectant IPA

Market area: EU

Surface disinfection liquid classic

Market area: EU

sterile IPA

Market area: EU

mikrozid® sterile liquid

Market area: EU

Surface disinfection liquid sterile

Market area: EU

BTS 6000

Market area: EU

Halades Alco

Market area: EU

Authorisation number

EU-0023656-0001 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

 

Active Substance

67-63-0

200-661-7

63,1

META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

Identifier

meta SPC 2 perform wipes IPA

1.2.   Suffix to the authorisation number

Number

1-2

1.3.   Product type(s)

Product type(s)

PT04 - Food and feed area (Disinfectants)

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

2.   META SPC 2 COMPOSITION

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

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

 

Active Substance

67-63-0

200-661-7

63,1

63,1

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

Formulation(s)

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

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

Hazard statements

Highly flammable liquid and vapour.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

Keep container tightly closed.

Ground and bond container and receiving equipment.

Use explosion-proof electrical/ventilating/lighting equipment.

Use non-sparking tools.

Take action to prevent static discharges.

Avoid breathing vapours.

Avoid breathing spray.

Use only outdoors or in a well-ventilated area.

Wear eye protection.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Call a POISON CENTER or doctor if you feel unwell.

If eye irritation persists:Get medical advice.

If eye irritation persists:Get medical attention.

In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.

Store in a well-ventilated place.Keep cool.

Store locked up.

Dispose of contents to /container to an approved waste disposal plant.

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

4.1.   Use description

Table 5

Use # 1 – Disinfection of surfaces - wiping

Product type

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

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: viruses (limited spectrum virucidal activity)

Common name: -

Development stage: -

Field(s) of use

Indoor

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

Application method(s)

Method: Wiping

Detailed description:

Product will be wiped directly on the surface.

Application rate(s) and frequency

Application Rate: Ready-to-use wipes

Dilution (%): -

Number and timing of application:

Disinfection after each production and cleaning process or when required according to SOP.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Soft pack: 1-200 wipes

Packaging material: LDPE/Alu/PET; LDPE/PET; biaxially oriented polypropylene (BOPP) + cast polypropylene (CPP)

Pouch: 10-200 wipes

Packaging material: LDPE/PET

Tube: 50-200 wipes

Packaging material: HDPE

closure material is either PP, PE3385

4.1.1.   Use-specific instructions for use

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

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

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

See general directions for use.

4.2.   Use description

Table 6

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

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

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

Application method(s)

Method: Wiping

Detailed description:

Product will be wiped directly on the surface.

Application rate(s) and frequency

Application Rate: Ready-to-use wipes

Dilution (%): -

Number and timing of application:

Disinfection after each production and cleaning process or when required according to SOP.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Soft pack: 1-200 wipes

Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP

Pouch: 10-200 wipes

Packaging material: LDPE/PET

Tube: 50-200 wipes

Packaging material: HDPE

closure material is either PP, PE3385

4.2.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).

4.2.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

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

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2

5.1.   Instructions for use

Clean the surface carefully before use.

Remove excess water from the surface before disinfection, if appropriate.

Make sure to wet surfaces completely.

Used wipes must be disposed in a closed container.

5.2.   Risk mitigation measures

The product must only be applied for disinfection of small surfaces.

Ensure adequate ventilation to prevent the formation of explosive atmospheres.

Avoid contact with eyes.

Keep out of reach of children and pets.

Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:

In case of accident: Call a poison centre or a doctor.

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

If on skin: Wash with water. If skin irritation occurs: Get medical advice.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.

5.4.   Instructions for safe disposal of the product and its packaging

-

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

Shelf-life: 24 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

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

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

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

Trade name(s)

perform classic wipes IPA

Market area: EU

 

buraton® wipes IPA

Market area: EU

perform® advanced wipes IPA

Market area: EU

arcana® wipes IPA

Market area: EU

clear IPA wipes

Market area: EU

pure IPA wipes

Market area: EU

disinfectant IPA wipes

Market area: EU

Surface disinfection wipes classic

Market area: EU

perform® sterile wipes IPA

Market area: EU

sterile IPA wipes

Market area: EU

mikrozid® sterile wipes

Market area: EU

Surface disinfection wipes sterile

Market area: EU

Authorisation number

EU-0023656-0002 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

 

Active Substance

67-63-0

200-661-7

63,1

META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

Identifier

meta SPC 3 mikrozid liquid

1.2.   Suffix to the authorisation number

Number

1-3

1.3.   Product type(s)

Product type(s)

PT04 - Food and feed area (Disinfectants)

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

2.   META SPC 3 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

 

Active Substance

67-63-0

200-661-7

63,1

63,1

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

Formulation(s)

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

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

Hazard statements

Highly flammable liquid and vapour.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

Keep container tightly closed.

Ground and bond container and receiving equipment.

Use explosion-proof electrical/ventilating/lighting equipment.

Use non-sparking tools.

Take action to prevent static discharges.

Avoid breathing vapours.

Avoid breathing spray.

Use only outdoors or in a well-ventilated area.

Wear eye protection.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Call a POISON CENTER or doctor if you feel unwell.

If eye irritation persists:Get medical advice.

If eye irritation persists:Get medical attention.

In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.

Store in a well-ventilated place.Keep cool.

Store locked up.

Dispose of contents to /container to an approved waste disposal plant.

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

4.1.   Use description

Table 7

Use # 1 – Disinfection of surfaces - spraying

Product type

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

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria including Mycobacterium tuberculosis

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: viruses (limited spectrum virucidal activity)

Common name: -

Development stage: -

Field(s) of use

Indoor

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

Application method(s)

Method: Spraying

Detailed description:

Product will be sprayed directly on the surface

Application rate(s) and frequency

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

Dilution (%): -

Number and timing of application:

Disinfection when required according to SOP.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 250-1000 ml

packaging material: HDPE, surlyn/PP

closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP

canister: 5-30 litre

packaging material: HDPE.

closure material is either: HDPE/LDPE

Revolver BAG: 1 litre

packaging material: EVA

Closure : PP/Silicone/EVA

drum: 200 - 220 litre

packaging material: HDPE

closure material is either: PP

IBC:900-1000 litre

packaging material: HDPE with steel frame closure material is either: PP, HDPE

4.1.1.   Use-specific instructions for use

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

4.1.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.

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

See general directions for use.

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

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

See general directions for use.

4.2.   Use description

Table 8

Use # 2 – Disinfection of surfaces - wiping

Product type

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

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria including Mycobacterium tuberculosis

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: viruses (limited spectrum virucidal activity)

Common name: -

Development stage: -

Field(s) of use

Indoor

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

Application method(s)

Method: Wiping

Detailed description:

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

Application rate(s) and frequency

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

Dilution (%): -

Number and timing of application:

Disinfection when required according to SOP.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 250-1000 ml

packaging material: HDPE, surlyn/PP

closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP

canister: 5-30 litre

packaging material: HDPE.

closure material is either: HDPE/LDPE

Revolver BAG: 1 litre

packaging material: EVA

Closure : PP/Silicone/EVA

drum: 200 - 220 litre

packaging material: HDPE

closure material is either: PP

IBC:900-1000 litre

packaging material: HDPE with steel frame

closure material is either: PP, HDPE

4.2.1.   Use-specific instructions for use

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

4.2.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.

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

See general directions for use.

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

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

See general directions for use.

4.3.   Use description

Table 9

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

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria including Mycobacterium tuberculosis

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

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

Application method(s)

Method: Spraying

Detailed description:

Product will be sprayed directly on the surface.

Application rate(s) and frequency

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

Dilution (%): -

Number and timing of application:

Disinfection when required according to SOP.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 250-1000 ml

packaging material: HDPE, surlyn/PP

closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP

canister: 5-30 litre

packaging material: HDPE.

closure material is either: HDPE/LDPE

Revolver BAG: 1 litre

packaging material: EVA

Closure : PP/Silicone/EVA

drum: 200 - 220 litre

packaging material: HDPE

closure material is either: PP

IBC: 900-1000 litre

packaging material: HDPE with steel frame closure material is either: PP, HDPE

4.3.1.   Use-specific instructions for use

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

4.3.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.

4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

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

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

See general directions for use.

4.4.   Use description

Table 10

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

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria including Mycobacterium tuberculosis

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

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

Application method(s)

Method: Wiping

Detailed description:

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

Application rate(s) and frequency

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

Dilution (%): -

Number and timing of application:

Disinfection when required according to SOP.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 250-1000 ml

packaging material: HDPE, surlyn/PP

closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP

canister: 5-30 litre

packaging material: HDPE.

closure material is either: HDPE/LDPE

Revolver BAG: 1 litre

packaging material: EVA

closure material: PP/Silicone/EVA

drum: 200 - 220 litre

packaging material: HDPE

closure material is either: PP

IBC: 900-1000 litre

packaging material: HDPE with steel frame closure material is either: PP, HDPE

4.4.1.   Use-specific instructions for use

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

4.4.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.

4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

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

See general directions for use.

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

5.1.   Instructions for use

Clean the surface carefully before use.

Remove excess water from the surface before disinfection, if appropriate.

Do not apply more than 25 ml/m2.

Make sure to wet surfaces completely.

Used wipes must be disposed in a closed container.

5.2.   Risk mitigation measures

The product must only be applied for disinfection of small surfaces.

Ensure adequate ventilation to prevent the formation of explosive atmospheres.

Avoid contact with eyes.

Apply a funnel for refilling.

Keep out of reach of children and pets.

Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:

In case of accident: Call a poison centre or a doctor.

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

If on skin: Wash with water. If skin irritation occurs: Get medical advice.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.

5.4.   Instructions for safe disposal of the product and its packaging

-

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

Shelf-life: 36 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

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

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3

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

Trade name(s)

mikrozid® classic liquid

Market area: EU

 

mikrozid® IPA liquid

Market area: EU

Surface Disinfection liquid pure

Market area: EU

Authorisation number

EU-0023656-0003 1-3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

 

Active Substance

67-63-0

200-661-7

63,1

META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier

Identifier

meta SPC 4 mikrozid wipes

1.2.   Suffix to the authorisation number

Number

1-4

1.3.   Product type(s)

Product type(s)

PT04 - Food and feed area (Disinfectants)

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

2.   META SPC 4 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 4

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

 

Active Substance

67-63-0

200-661-7

63,1

63,1

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

Formulation(s)

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

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

Hazard statements

Highly flammable liquid and vapour.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

Keep container tightly closed.

Ground and bond container and receiving equipment.

Use explosion-proof electrical/ventilating/lighting equipment.

Use non-sparking tools.

Take action to prevent static discharges.

Avoid breathing vapours.

Avoid breathing spray.

Use only outdoors or in a well-ventilated area.

Wear eye protection.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Call a POISON CENTER or doctor if you feel unwell.

If eye irritation persists:Get medical advice.

If eye irritation persists:Get medical attention.

In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.

Store in a well-ventilated place.Keep cool.

Store locked up.

Dispose of contents to /container to an approved waste disposal plant.

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

4.1.   Use description

Table 11

Use # 1 – Disinfection of surfaces - wiping

Product type

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

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria including Mycobacterium tuberculosis

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: viruses (limited spectrum virucidal activity)

Common name: -

Development stage: -

Field(s) of use

Indoor

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

Application method(s)

Method: Wiping

Detailed description:

Product will be wiped directly on the surface.

Application rate(s) and frequency

Application Rate: Ready-to-use wipes

Dilution (%): -

Number and timing of application:

Disinfection when required according to SOP.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Soft pack: 1-200 wipes

Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP

Pouch: 10-200 wipes

Packaging material: LDPE/PET

Tube: 50-200 wipes

Packaging material: HDPE

closure material is either PP, PE3385

4.1.1.   Use-specific instructions for use

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

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

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

See general directions for use.

4.2.   Use description

Table 12

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

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria including Mycobacterium tuberculosis

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

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

Application method(s)

Method: Wiping

Detailed description:

Product will be wiped directly on the surface.

Application rate(s) and frequency

Application Rate: Ready-to-use wipes

Dilution (%): -

Number and timing of application:

Disinfection when required according to SOP.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Soft pack: 1-200 wipes

Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP

Pouch: 10-200 wipes

Packaging material: LDPE/PET

Tube: 50-200 wipes

Packaging material: HDPE

closure material is either PP, PE3385

4.2.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).

4.2.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

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

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (4) OF THE META SPC 4

5.1.   Instructions for use

Clean the surface carefully before use.

Remove excess water from the surface before disinfection, if appropriate.

Make sure to wet surfaces completely.

Used wipes must be disposed in a closed container.

5.2.   Risk mitigation measures

The product must only be applied for disinfection of small surfaces.

Ensure adequate ventilation to prevent the formation of explosive atmospheres.

Avoid contact with eyes.

Keep out of reach of children and pets.

Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:

In case of accident: Call a poison centre or a doctor.

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

If on skin: Wash with water. If skin irritation occurs: Get medical advice.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.

5.4.   Instructions for safe disposal of the product and its packaging

-

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

Shelf-life: 24 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

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

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4

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

Trade name(s)

mikrozid® classic wipes

Market area: EU

 

mikrozid® IPA wipes

Market area: EU

surface disinfection wipes classic

Market area: EU

Authorisation number

EU-0023656-0004 1-4

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

 

Active Substance

67-63-0

200-661-7

63,1

META SPC 5

1.   META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier

Identifier

meta SPC 5 kodan wipes IPA pro

1.2.   Suffix to the authorisation number

Number

1-5

1.3.   Product type(s)

Product type(s)

PT04 - Food and feed area (Disinfectants)

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

2.   META SPC 5 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 5

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

 

Active Substance

67-63-0

200-661-7

63,1

63,1

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

Formulation(s)

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

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

Hazard statements

Highly flammable liquid and vapour.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

Keep container tightly closed.

Ground and bond container and receiving equipment.

Use explosion-proof electrical/ventilating/lighting equipment.

Use non-sparking tools.

Take action to prevent static discharges.

Avoid breathing vapours.

Avoid breathing spray.

Use only outdoors or in a well-ventilated area.

Wear eye protection.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Call a POISON CENTER or doctor if you feel unwell.

If eye irritation persists:Get medical advice.

If eye irritation persists:Get medical attention.

In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.

Store in a well-ventilated place.Keep cool.

Store locked up.

Dispose of contents to /container to an approved waste disposal plant.

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

4.1.   Use description

Table 13

Use # 1 – Disinfection of surfaces - wiping

Product type

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

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria including Mycobacterium tuberculosis

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: viruses (limited spectrum virucidal activity)

Common name: -

Development stage: -

Field(s) of use

Indoor

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

Application method(s)

Method: Wiping

Detailed description:

Product will be wiped directly on the surface.

Application rate(s) and frequency

Application Rate: Ready-to-use wipes

Dilution (%): -

Number and timing of application:

-

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Soft pack: 1-200 wipes

Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP

Pouch: 10-200 wipes

Packaging material: LDPE/PET

Tube: 50-200 wipes

Packaging material: HDPE

closure material is either PP, PE3385

4.1.1.   Use-specific instructions for use

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

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

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

See general directions for use.

4.2.   Use description

Table 14

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

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria including Mycobacterium tuberculosis

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

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

Application method(s)

Method: Wiping

Detailed description:

Product will be wiped directly on the surface.

Application rate(s) and frequency

Application Rate: Ready-to-use wipes

Dilution (%): -

Number and timing of application:

-

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Soft pack: 1-200 wipes

Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP

Pouch: 10-200 wipes

Packaging material: LDPE/PET

Tube: 50-200 wipes

Packaging material: HDPE

closure material is either PP, PE3385

4.2.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).

4.2.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

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

See general directions for use.

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

5.1.   Instructions for use

Clean the surface carefully before use.

Remove excess water from the surface before disinfection, if appropriate.

Make sure to wet surfaces completely.

Used wipes must be disposed in a closed container.

5.2.   Risk mitigation measures

The product must only be applied for disinfection of small surfaces.

Ensure adequate ventilation to prevent the formation of explosive atmospheres.

Avoid contact with eyes.

Keep out of reach of children and pets.

Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:

In case of accident: Call a poison centre or a doctor.

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

If on skin: Wash with water. If skin irritation occurs: Get medical advice.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.

5.4.   Instructions for safe disposal of the product and its packaging

-

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

Shelf-life: 24 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

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

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5

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

Trade name(s)

kodan® wipes pure

Market area: EU

 

schülke® classic wipes

Market area: EU

Authorisation number

EU-0023656-0005 1-5

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

 

Active Substance

67-63-0

200-661-7

63,1

META SPC 6

1.   META SPC 6 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 6 identifier

Identifier

meta SPC 6 kodan wipes IPA

1.2.   Suffix to the authorisation number

Number

1-6

1.3.   Product type(s)

Product type(s)

PT04 - Food and feed area (Disinfectants)

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

2.   META SPC 6 COMPOSITION

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

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

 

Active Substance

67-63-0

200-661-7

63,1

63,1

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

Formulation(s)

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

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6

Hazard statements

Highly flammable liquid and vapour.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

If medical advice is needed, have product container or label at hand.

Keep out of reach of children.

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

Keep container tightly closed.

Ground and bond container and receiving equipment.

Use explosion-proof electrical/ventilating/lighting equipment.

Use non-sparking tools.

Take action to prevent static discharges.

Avoid breathing vapours.

Avoid breathing spray.

Use only outdoors or in a well-ventilated area.

IF INHALED:Remove person to fresh air and keep comfortable for breathing.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Call a POISON CENTER or doctor if you feel unwell.

If eye irritation persists:Get medical advice.

If eye irritation persists:Get medical attention.

In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.

Store in a well-ventilated place.Keep cool.

Store locked up.

Dispose of contents to /container to an approved waste disposal plant.

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

4.1.   Use description

Table 15

Use # 1 – Disinfection of surfaces - wiping

Product type

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

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria including Mycobacterium tuberculosis

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: viruses (limited spectrum virucidal activity)

Common name: -

Development stage: -

Field(s) of use

Indoor

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

Application method(s)

Method: Wiping

Detailed description:

Product will be wiped directly on the surface.

Application rate(s) and frequency

Application Rate: Ready-to-use wipes

Dilution (%): -

Number and timing of application:

-

Category(ies) of users

Industrial

Professional

General public (non-professional)

Pack sizes and packaging material

Soft pack: 1-200 wipes

Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP

Pouch: 10-200 wipes

Packaging material: LDPE/PET

Tube: 50-200 wipes

Packaging material: HDPE

closure material is either PP, PE3385

4.1.1.   Use-specific instructions for use

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

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

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

See general directions for use.

4.2.   Use description

Table 16

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

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria including Mycobacterium tuberculosis

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

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

Application method(s)

Method: Wiping

Detailed description:

Product will be wiped directly on the surface.

Application rate(s) and frequency

Application Rate: Ready-to-use wipes

Dilution (%): -

Number and timing of application:

-

Category(ies) of users

Industrial

Professional

General public (non-professional)

Pack sizes and packaging material

Soft pack: 1-200 wipes

Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP

Pouch: 10-200 wipes

Packaging material: LDPE/PET

Tube: 50-200 wipes

Packaging material: HDPE

closure material is either PP, PE3385

4.2.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).

4.2.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

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

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (6) OF THE META SPC 6

5.1.   Instructions for use

Clean the surface carefully before use.

Remove excess water from the surface before disinfection, if appropriate.

Make sure to wet surfaces completely.

Used wipes must be disposed in a closed container.

5.2.   Risk mitigation measures

The product must only be applied for disinfection of small surfaces.

Ensure adequate ventilation to prevent the formation of explosive atmospheres.

Avoid contact with eyes.

Keep out of the reach of children and pets.

Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:

In case of accident: Call a poison centre or a doctor.

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

If on skin: Wash with water. If skin irritation occurs: Get medical advice.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.

5.4.   Instructions for safe disposal of the product and its packaging

-

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

Shelf-life: 24 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

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

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6

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

Trade name(s)

schülke Hygiene-Tücher

Market area: EU

 

SOS Desinfizierende Feuchttücher

Market area: EU

SOS Hygiene-Tücher

Market area: EU

kodan® clean comfort wipes

Market area: EU

schülke clean comfort wipes

Market area: EU

Hygiene-Tücher

Market area: EU

Desinfizierende Feuchttücher

Market area: EU

Desinfektionstücher

Market area: EU

clean comfort wipes

Market area: EU

disinfecting wipes

Market area: EU

Authorisation number

EU-0023656-0006 1-6

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

 

Active Substance

67-63-0

200-661-7

63,1

META SPC 7

1.   META SPC 7 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 7 identifier

Identifier

meta SPC 7 AntiLy SD

1.2.   Suffix to the authorisation number

Number

1-7

1.3.   Product type(s)

Product type(s)

PT04 - Food and feed area (Disinfectants)

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

2.   META SPC 7 COMPOSITION

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

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

 

Active Substance

67-63-0

200-661-7

63,1

63,1

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

Formulation(s)

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

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7

Hazard statements

Highly flammable liquid and vapour.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

Keep container tightly closed.

Ground and bond container and receiving equipment.

Use explosion-proof electrical/ventilating/lighting equipment.

Use non-sparking tools.

Take action to prevent static discharges.

Avoid breathing vapours.

Avoid breathing spray.

Use only outdoors or in a well-ventilated area.

Wear eye protection.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Call a POISON CENTER or doctor if you feel unwell.

If eye irritation persists:Get medical advice.

If eye irritation persists:Get medical attention.

In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.

Store in a well-ventilated place.Keep cool.

Store locked up.

Dispose of contents to /container to an approved waste disposal plant.

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

4.1.   Use description

Table 17

Use # 1 – Disinfection of surfaces - spraying

Product type

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

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Field(s) of use

Indoor

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

Application method(s)

Method: Spraying

Detailed description:

Product will be sprayed directly on the surface.

Application rate(s) and frequency

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

Dilution (%): -

Number and timing of application:

-

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 125-1000 ml

packaging material: HDPE

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

4.1.1.   Use-specific instructions for use

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

4.1.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.

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

See general directions for use.

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

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

See general directions for use.

4.2.   Use description

Table 18

Use # 2 – Disinfection of surfaces - wiping

Product type

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

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Field(s) of use

Indoor

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

Application method(s)

Method: Wiping

Detailed description:

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

Application rate(s) and frequency

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

Dilution (%): -

Number and timing of application:

-

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 125-1000 ml

packaging material: HDPE

Clack cap material: PP

Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel);

Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)

Canister: 5-30 litre

packaging material: HDPE

closure material: HDPE

4.2.1.   Use-specific instructions for use

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

4.2.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.

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

See general directions for use.

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

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

See general directions for use.

4.3.   Use description

Table 19

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

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

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

Application method(s)

Method: Spraying

Detailed description:

Product will be sprayed directly on the surface.

Application rate(s) and frequency

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

Dilution (%): -

Number and timing of application:

-

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 125-1000 ml

packaging material: HDPE

Clack cap material: PP

Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)

Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)

4.3.1.   Use-specific instructions for use

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

4.3.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.

4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

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

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

See general directions for use.

4.4.   Use description

Table 20

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

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

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

Application method(s)

Method: Wiping

Detailed description:

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

Application rate(s) and frequency

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

Dilution (%): -

Number and timing of application:

-

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Bottle: 125-1000 ml

packaging material: HDPE

Clack cap material: PP

Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)

Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)

Canister: 5-30 litre

packaging material: HDPE

closure material: HDPE

4.4.1.   Use-specific instructions for use

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

4.4.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.

4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

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

See general directions for use.

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

5.1.   Instructions for use

Clean the surface carefully before use.

Remove excess water from the surface before disinfection, if appropriate.

Do not apply more than 25 ml/m2.

Make sure to wet surfaces completely.

Used wipes must be disposed in a closed container.

5.2.   Risk mitigation measures

The product must only be applied for disinfection of small surfaces.

Ensure adequate ventilation to prevent the formation of explosive atmospheres.

Avoid contact with eyes.

Apply a funnel for refilling.

Keep out of reach of children and pets.

Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:

In case of accident: Call a poison centre or a doctor.

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

If on skin: Wash with water. If skin irritation occurs: Get medical advice.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.

5.4.   Instructions for safe disposal of the product and its packaging

-

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

Shelf-life: 36 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

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

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7

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

Trade name(s)

AntiLy 5

Market area: EU

Authorisation number

EU-0023656-0007 1-7

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

 

Active Substance

67-63-0

200-661-7

63,1

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

Trade name(s)

AntiLy 6

Market area: EU

Authorisation number

EU-0023656-0008 1-7

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

 

Active Substance

67-63-0

200-661-7

63,1

META SPC 8

1.   META SPC 8 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 8 identifier

Identifier

meta SPC 8 AntiLy SD wipes

1.2.   Suffix to the authorisation number

Number

1-8

1.3.   Product type(s)

Product type(s)

PT04 - Food and feed area (Disinfectants)

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

2.   META SPC 8 COMPOSITION

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

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

 

Active Substance

67-63-0

200-661-7

63,1

63,1

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

Formulation(s)

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

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8

Hazard statements

Highly flammable liquid and vapour.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.

Keep container tightly closed.

Ground and bond container and receiving equipment.

Use explosion-proof electrical/ventilating/lighting equipment.

Use non-sparking tools.

Take action to prevent static discharges.

Avoid breathing vapours.

Avoid breathing spray.

Use only outdoors or in a well-ventilated area.

Wear eye protection.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Call a POISON CENTER or doctor if you feel unwell.

If eye irritation persists:Get medical advice.

If eye irritation persists:Get medical attention.

In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.

Store in a well-ventilated place.Keep cool.

Store locked up.

Dispose of contents to /container to an approved waste disposal plant.

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

4.1.   Use description

Table 21

Use # 1 – Disinfection of surfaces - wiping

Product type

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

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Field(s) of use

Indoor

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

Application method(s)

Method: Wiping

Detailed description:

Product will be wiped directly on the surface.

Application rate(s) and frequency

Application Rate: Ready-to-use wipes

Dilution (%): -

Number and timing of application:

-

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Can: 100-150 wipes

Packaging: HDPE

Closure material: HDPE

Pack: 100-150 wipes

Packaging: PET/PE

4.1.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

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

See general directions for use.

4.2.   Use description

Table 22

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

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

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

Application method(s)

Method: Wiping

Detailed description:

Product will be wiped directly on the surface.

Application rate(s) and frequency

Application Rate: Ready-to-use wipes

Dilution (%): -

Number and timing of application:

-

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Can: 100-150 wipes

Packaging: HDPE

Closure material: HDPE

Pack: 100-150 wipes

Packaging: PET/PE

4.2.1.   Use-specific instructions for use

Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20± 2°C).

4.2.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

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

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (8) OF THE META SPC 8

5.1.   Instructions for use

Clean the surface carefully before use.

Remove excess water from the surface before disinfection, if appropriate.

Make sure to wet surfaces completely.

Used wipes must be disposed in a closed container.

5.2.   Risk mitigation measures

The product must only be applied for disinfection of small surfaces.

Ensure adequate ventilation to prevent the formation of explosive atmospheres.

Avoid contact with eyes.

Keep out of reach of children and pets.

Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First aid:

In case of accident: Call a poison centre or a doctor.

IF INHALED: Remove person to fresh air and keep comfortable for breathing.

If on skin: Wash with water. If skin irritation occurs: Get medical advice.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.

5.4.   Instructions for safe disposal of the product and its packaging

-

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

Shelf-life: 24 months

Keep container tightly closed.

Store in a well-ventilated place.

Protect from sunlight.

Store at room temperature in the original container.

6.   OTHER INFORMATION

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

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8

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

Trade name(s)

AntiLy 5 wipes

Market area: EU

Authorisation number

EU-0023656-0009 1-8

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

 

Active Substance

67-63-0

200-661-7

63,1

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

Trade name(s)

AntiLy 6 wipes

Market area: EU

Authorisation number

EU-0023656-0010 1-8

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

 

Active Substance

67-63-0

200-661-7

63,1


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

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

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

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

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

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

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

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


ELI: http://data.europa.eu/eli/reg_impl/2024/2194/oj

ISSN 1977-0677 (electronic edition)