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Document 32024R2194

    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

    C/2024/6022

    OJ L, 2024/2194, 5.9.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/2194/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    Legal status of the document In force

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

    European flag

    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)


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