title: Commission Implementing Regulation (EU) 2020/1991 of 27 November 2020 granting a Union authorisation for the biocidal product family ‘perform-IPA’ (Text with EEA relevance)

text:
                  7.12.2020

                  EN

                  Official Journal of the European Union

                  L 410/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1991
         of 27 November 2020
         granting a Union authorisation for the biocidal product family ‘perform-IPA’
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5) thereof,
         Whereas:

                     (1)

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

                     (2)

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

                     (3)

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

                     (4)

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

                     (5)

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

                     (6)

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

                     (7)

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

                     (8)

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

                     (9)

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

               HAS ADOPTED THIS REGULATION:

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

            Article 2
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 27 November 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

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

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

            ANNEX

               Summary of product characteristics for a biocidal product family

            perform-IPA
            Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
            Product type 4 – Food and feed area (Disinfectants)
            Authorisation number: EU-0023656-0000
            R4BP asset number: EU-0023656-0000
            PART I

               FIRST INFORMATION LEVEL

            1.   ADMINISTRATIVE INFORMATION

            1.1.   Family name

                        Name

                        perform-IPA

                  1.2.   Product type(s)

                        Product type(s)

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

                  1.3.   Authorisation holder

                        Name and address of the authorisation holder

                        Name

                        Schülke & Mayr GmbH

                        Address

                        Robert-Koch-Str. 2, 22851 Norderstedt, Germany

                        Authorisation number

                        EU-0023656-0000

                           R4BP asset number

                        EU-0023656-0000

                        Date of the authorisation

                        27 December 2020

                        Expiry date of the authorisation

                        30 November 2030

                  1.4.   Manufacturer(s) of the biocidal products

                        Name of manufacturer

                        Schülke & Mayr GmbH

                        Address of manufacturer

                        Robert-Koch-Str. 2, 22851 Norderstedt, Germany

                        Location of manufacturing sites

                        Robert-Koch-Str. 2, 22851 Norderstedt, Germany

                        Name of manufacturer

                        BOCHEMIE a.s.

                        Address of manufacturer

                        Lidická 326, 735 95 Bohumín Czech Republic

                        Location of manufacturing sites

                        Lidická 326, 735 95 Bohumín Czech Republic

                        Name of manufacturer

                        Imeco

                        Address of manufacturer

                        Boschstr. 5, 63768 Hösbach Germany

                        Location of manufacturing sites

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

                        Name of manufacturer

                        Tristel Solutions Limited

                        Address of manufacturer

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

                        Location of manufacturing sites

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

                        Name of manufacturer

                        Techtex

                        Address of manufacturer

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

                        Location of manufacturing sites

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

                        Name of manufacturer

                        A.F.P. GmbH

                        Address of manufacturer

                        Otto Brenner Straße 16, 21337 Lüneburg Germany

                        Location of manufacturing sites

                        Otto Brenner Straße 16, 21337 Lüneburg Germany

                        Name of manufacturer

                        Innovate GmbH

                        Address of manufacturer

                        Am Hohen Stein 11, 06618 Naumburg (Saale) Germany

                        Location of manufacturing sites

                        Am Hohen Stein 11, 06618 Naumburg (Saale) Germany

                        Name of manufacturer

                        Lysoform Dr. Hans Rosemann GmbH

                        Address of manufacturer

                        Kaiser-Wilhelm-Straße 133, 12247 Berlin Germany

                        Location of manufacturing sites

                        Kaiser-Wilhelm-Straße 133, 12247 Berlin Germany

                        Name of manufacturer

                        Sterisol AB

                        Address of manufacturer

                        Kronoängsgatan 3, 592 23 Vadstena Sweden

                        Location of manufacturing sites

                        Kronoängsgatan 3, 592 23 Vadstena Sweden

                        Name of manufacturer

                        Rudolf Dankwardt GmbH

                        Address of manufacturer

                        Gutenbergring 50-52, 22848 Norderstedt Germany

                        Location of manufacturing sites

                        Gutenbergring 50-52, 22848 Norderstedt Germany
                        Lagerstr. 15, 19249 Jessenitz - Werk / Lübtheen Germany

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

                        Active substance

                        Propan-2-ol

                        Name of manufacturer

                        Ineos Solvents Germany GmbH (formerly Sasol)

                        Address of manufacturer

                        Römerstraße 733, 47443 Moers Germany

                        Location of manufacturing sites

                        Römerstraße 733, 47443 Moers Germany
                        Shamrockstr. 88, 44643 Herne Germany

                        Active substance

                        Propan-2-ol

                        Name of manufacturer

                        Shell Chemicals Europe B.V.

                        Address of manufacturer

                        Postbus 2334, 3000 CH Rotterdam Netherlands

                        Location of manufacturing sites

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

                  2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

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

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        63,1

                        63,1

                  2.2.   Type(s) of formulation

                        Formulation(s)

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

                  PART II

               SECOND INFORMATION LEVEL – META SPC(S)

               META SPC 1

            1.   META SPC 1 ADMINISTRATIVE INFORMATION

            1.1.   Meta SPC 1 identifier

                        Identifier

                        meta SPC 1 perform IPA liquid

                  1.2.   Suffix to the authorisation number

                        Number

                        1-1

                  1.3.   Product type(s)

                        Product type(s)

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

                  2.   META SPC 1 COMPOSITION

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

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        63,1

                        63,1

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

                        Formulation(s)

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

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

                        Hazard statements

                        Highly flammable liquid and vapour.
                        Causes serious eye irritation.
                        May cause drowsiness or dizziness.
                        Repeated exposure may cause skin dryness or cracking.

                        Precautionary statements

                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.
                        Keep container tightly closed.
                        Ground and bond container and receiving equipment.
                        Use explosion-proof electrical/ventilating/lighting equipment.
                        Use non-sparking tools.
                        Take action to prevent static discharges.
                        Avoid breathing vapours.
                        Avoid breathing spray.
                        Use only outdoors or in a well-ventilated area.
                        Wear eye protection.
                        IF IN EYES:Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        Call a POISON CENTER or doctor if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        If eye irritation persists: Get medical attention.
                        In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
                        Store in a well-ventilated place. Keep cool.
                        Store locked up.
                        Dispose of contents to /container to an approved waste disposal plant.

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

            4.1.   Use description

               Table 1. Use # 1 – Disinfection of surfaces - spraying

                        Product type

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

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

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

                        Field(s) of use

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

                        Application method(s)

                        Spraying
                        Product will be sprayed directly on the surface

                        Application rate(s) and frequency

                        Ready-to-use. Do not apply more than 25 ml/m2.
                        Disinfection after each production and cleaning process or when required according to standard operating procedure (SOP)

                        Category(ies) of users

                        Industrial
                        Professional

                        Pack sizes and packaging material

                        Bottle: 250-1000 ml
                        packaging material: high-density polyethylene (HDPE), surlyn/polypropylene (PP)
                        closure material is either: PP, polyoxymethylene (POM), low-density polyethylene (LDPE), HDPE, polyethylene (PE), ethylene-vinyl acetate (EVA), stainless steel, polybutylene terephthalate (PBT), (LD)PE, exp. polytetrafluoroethylene (PTFE), linear low density polyethylene (LLDPE), expanded PE (EXPPE), Co Polymer PP
                        canister: 5-10 L
                        packaging material: HDPE.
                        closure material is either: HDPE/LDPE
                        Revolver BAG: 1 L
                        packaging material: EVA
                        closure material: PP/Silicone/EVA

                  4.1.1.   Use-specific instructions for use

            Spray ready-to-use product on the surface and allow to take effect at room temperature (20± 2°C) for at least 1 minute.
            4.1.2.   Use-specific risk mitigation measures

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

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

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

            See general directions for use.
            4.2.   Use description

               Table 2. Use # 2 – Disinfection of surfaces - wiping

                        Product type

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

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

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

                        Field(s) of use

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

                        Application method(s)

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

                        Application rate(s) and frequency

                        Ready-to-use. Do not apply more than 25 ml/m2.
                        Disinfection after each production and cleaning process or when required according to SOP.

                        Category(ies) of users

                        Industrial
                        Professional

                        Pack sizes and packaging material

                        Bottle: 250-1000 ml
                        packaging material: HDPE, surlyn/PP
                        closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP.
                        canister: 5-10 L
                        packaging material: HDPE.
                        closure material is either: HDPE/LDPE
                        Revolver BAG: 1 L
                        packaging material: EVA
                        closure material: PP/Silicone/EVA.

                  4.2.1.   Use-specific instructions for use

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

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

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

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

            See general directions for use.
            4.3.   Use description

               Table 3. Use # 3 – disinfection of surfaces with food and feed contact - spraying

                        Product type

                        PT04 - Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

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

                        Field(s) of use

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

                        Application method(s)

                        Spraying
                        Product will be sprayed directly on the surface.

                        Application rate(s) and frequency

                        Ready-to-use. Do not apply more than 25 ml/m2.
                        Disinfection after each production and cleaning process or when required according to SOP.

                        Category(ies) of users

                        Industrial
                        Professional

                        Pack sizes and packaging material

                        Bottle: 250-1000 ml
                        packaging material: HDPE, surlyn/PP
                        closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP.
                        canister: 5-10 L
                        packaging material: HDPE.
                        closure material is either: HDPE/LDPE
                        Revolver BAG: 1 L
                        packaging material: EVA
                        closure material: PP/Silicone/EVA.

                  4.3.1.   Use-specific instructions for use

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

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

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

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

            See general directions for use.
            4.4.   Use description

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

                        Product type

                        PT04 - Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

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

                        Field(s) of use

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

                        Application method(s)

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

                        Application rate(s) and frequency

                        Ready-to-use. Do not apply more than 25 ml/m2.
                        Disinfection after each production and cleaning process or when required according to SOP.

                        Category(ies) of users

                        Industrial
                        Professional

                        Pack sizes and packaging material

                        Bottle: 250-1000 ml
                        packaging material: HDPE, surlyn/PP
                        closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP.
                        canister: 5-10 L
                        packaging material: HDPE.
                        closure material is either: HDPE/LDPE
                        Revolver BAG: 1 L
                        packaging material: EVA
                        closure material: PP/Silicone/EVA.

                  4.4.1.   Use-specific instructions for use

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

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

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

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

            See general directions for use.
            5.   GENERAL DIRECTIONS FOR USE (1)
               OF THE META SPC 1

            5.1.   Instructions for use

            Clean the surface carefully before use.
            Remove excess water from the surface before disinfection, if appropriate.
            Do not apply more than 25 ml/m2.
            Make sure to wet surfaces completely.
            Used wipes must be disposed in a closed container.
            5.2.   Risk mitigation measures

            The product must only be applied for disinfection of small surfaces.
            Ensure adequate ventilation to prevent the formation of explosive atmospheres.
            Avoid contact with eyes.
            Apply a funnel for refilling.
            Keep out of reach of children and pets.
            Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            First aid:

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

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

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

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

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

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

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

            Shelf-life: 36 months
            Keep container tightly closed.
            Store in a well-ventilated place.
            Protect from sunlight.
            Store at room temperature in the original container.
            6.   OTHER INFORMATION

            The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
            7.1.   Trade name(s), authorisation number and specific composition of each individual product

                        Trade name(s)

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

                        Authorisation number

                        EU-0023656-0001 1-1

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        63,1

               META SPC 2

            1.   META SPC 2 ADMINISTRATIVE INFORMATION

            1.1.   Meta SPC 2 identifier

                        Identifier

                        meta SPC 2 perform wipes IPA

                  1.2.   Suffix to the authorisation number

                        Number

                        1-2

                  1.3.   Product type(s)

                        Product type(s)

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

                  2.   META SPC 2 COMPOSITION

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

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        63,1

                        63,1

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

                        Formulation(s)

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

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

                        Hazard statements

                        Highly flammable liquid and vapour.
                        Causes serious eye irritation.
                        May cause drowsiness or dizziness.
                        Repeated exposure may cause skin dryness or cracking.

                        Precautionary statements

                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.
                        Keep container tightly closed.
                        Ground and bond container and receiving equipment.
                        Use explosion-proof electrical/ventilating/lighting equipment.
                        Use non-sparking tools.
                        Take action to prevent static discharges.
                        Avoid breathing vapours.
                        Avoid breathing spray.
                        Use only outdoors or in a well-ventilated area.
                        Wear eye protection.
                        IF IN EYES: Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
                        Call a POISON CENTER or doctor if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        If eye irritation persists: Get medical attention.
                        In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
                        Store in a well-ventilated place. Keep cool.
                        Store locked up.
                        Dispose of contents /container to an approved waste disposal plant.

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

            4.1.   Use description

               Table 5. Use # 1 – Disinfection of surfaces - wiping

                        Product type

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

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

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

                        Field(s) of use

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

                        Application method(s)

                        Wiping
                        Product will be wiped directly on the surface.

                        Application rate(s) and frequency

                        Ready-to-use wipes
                        Disinfection after each production and cleaning process or when required according to SOP.

                        Category(ies) of users

                        Industrial
                        Professional

                        Pack sizes and packaging material

                        Soft pack: 1-200 wipes
                        Packaging material: LDPE/Alu/PET; LDPE/PET; biaxially oriented polypropylene (BOPP) + cast polypropylene (CPP)
                        Pouch: 10-200 wipes
                        Packaging material: LDPE/PET
                        Tube: 50-200 wipes
                        Packaging material: HDPE
                        closure material is either PP, PE3385

                  4.1.1.   Use-specific instructions for use

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

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

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

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

            See general directions for use.
            4.2.   Use description

               Table 6. Use # 2 – Disinfection of surfaces with food and feed contact - wiping

                        Product type

                        PT04 - Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

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

                        Field(s) of use

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

                        Application method(s)

                        Wiping
                        Product will be wiped directly on the surface.

                        Application rate(s) and frequency

                        Ready-to-use wipes
                        Disinfection after each production and cleaning process or when required according to SOP.

                        Category(ies) of users

                        Industrial
                        Professional

                        Pack sizes and packaging material

                        Soft pack: 1-200 wipes
                        Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
                        Pouch: 10-200 wipes
                        Packaging material: LDPE/PET
                        Tube: 50-200 wipes
                        Packaging material: HDPE
                        closure material is either PP, PE3385

                  4.2.1.   Use-specific instructions for use

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

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

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

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

            See general directions for use.
            5.   GENERAL DIRECTIONS FOR USE (2)
               OF THE META SPC 2

            5.1.   Instructions for use

            Clean the surface carefully before use.
            Remove excess water from the surface before disinfection, if appropriate.
            Make sure to wet surfaces completely.
            Used wipes must be disposed in a closed container.
            5.2.   Risk mitigation measures

            The product must only be applied for disinfection of small surfaces.
            Ensure adequate ventilation to prevent the formation of explosive atmospheres.
            Avoid contact with eyes.
            Keep out of reach of children and pets.
            Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            First aid:

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

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

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

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

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

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

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

            Shelf-life: 24 months
            Keep container tightly closed.
            Store in a well-ventilated place.
            Protect from sunlight.
            Store at room temperature in the original container.
            6.   OTHER INFORMATION

            The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

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

                        Trade name(s)

                        perform classic wipes IPA
                        buraton® wipes IPA
                        perform® advanced wipes IPA
                        arcana® wipes IPA
                        clear IPA wipes
                        pure IPA wipes
                        disinfectant IPA wipes
                        Surface disinfection wipes classic
                        perform® sterile wipes IPA
                        sterile IPA wipes
                        mikrozid® sterile wipes
                        Surface disinfection wipes sterile

                        Authorisation number

                        EU-0023656-0002 1-2

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        63,1

               META SPC 3

            1.   META SPC 3 ADMINISTRATIVE INFORMATION

            1.1.   Meta SPC 3 identifier

                        Identifier

                        meta SPC 3 mikrozid liquid

                  1.2.   Suffix to the authorisation number

                        Number

                        1-3

                  1.3.   Product type(s)

                        Product type(s)

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

                  2.   META SPC 3 COMPOSITION

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

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        63,1

                        63,1

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

                        Formulation(s)

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

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

                        Hazard statements

                        Highly flammable liquid and vapour.
                        Causes serious eye irritation.
                        May cause drowsiness or dizziness.
                        Repeated exposure may cause skin dryness or cracking.

                        Precautionary statements

                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Keep container tightly closed.
                        Ground and bond container and receiving equipment.
                        Use explosion-proof electrical/ventilating/lighting equipment.
                        Use non-sparking tools.
                        Take action to prevent static discharges.
                        Avoid breathing vapours.
                        Avoid breathing spray.
                        Use only outdoors or in a well-ventilated area.
                        Wear eye protection.
                        IF IN EYES:Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        Call a POISON CENTER or doctor if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        If eye irritation persists: Get medical attention.
                        In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
                        Store in a well-ventilated place. Keep cool.
                        Store locked up.
                        Dispose of contents /container to an approved waste disposal plant.

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

            4.1.   Use description

               Table 7. Use # 1 – Disinfection of surfaces - spraying

                        Product type

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

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Scientific name: Bacteria including Mycobacterium tuberculosis

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

                        Field(s) of use

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

                        Application method(s)

                        Spraying
                        Product will be sprayed directly on the surface

                        Application rate(s) and frequency

                        Ready-to-use. Do not apply more than 25 ml/m2.
                        Disinfection when required according to SOP.

                        Category(ies) of users

                        Industrial
                        Professional

                        Pack sizes and packaging material

                        Bottle: 250-1000 ml
                        packaging material: HDPE, surlyn/PP
                        closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP
                        canister: 5-10 L
                        packaging material: HDPE.
                        closure material is either: HDPE/LDPE
                        Revolver BAG: 1 L
                        packaging material: EVA
                        Closure : PP/Silicone/EVA

                  4.1.1.   Use-specific instructions for use

            Spray ready-to-use product on the surface and allow to take effect at room temperature (20± 2°C) for at least 1 minute.
            4.1.2.   Use-specific risk mitigation measures

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

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

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

            See general directions for use.
            4.2.   Use description

               Table 8. Use # 2 – Disinfection of surfaces - wiping

                        Product type

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

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Scientific name: Bacteria including Mycobacterium tuberculosis

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

                        Field(s) of use

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

                        Application method(s)

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

                        Application rate(s) and frequency

                        Ready-to-use. Do not apply more than 25 ml/m2.
                        Disinfection when required according to SOP.

                        Category(ies) of users

                        Industrial
                        Professional

                        Pack sizes and packaging material

                        Bottle: 250-1000 ml
                        packaging material: HDPE, surlyn/PP
                        closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP
                        canister: 5-10 L
                        packaging material: HDPE.
                        closure material is either: HDPE/LDPE
                        Revolver BAG: 1 L
                        packaging material: EVA
                        Closure : PP/Silicone/EVA

                  4.2.1.   Use-specific instructions for use

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

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

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

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

            See general directions for use.
            4.3.   Use description

               Table 9. Use # 3 – disinfection of surfaces with food and feed contact - spraying

                        Product type

                        PT04 - Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Scientific name: Bacteria including Mycobacterium tuberculosis

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

                        Field(s) of use

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

                        Application method(s)

                        Spraying
                        Product will be sprayed directly on the surface.

                        Application rate(s) and frequency

                        Ready-to-use. Do not apply more than 25 ml/m2.
                        Disinfection when required according to SOP.

                        Category(ies) of users

                        Industrial
                        Professional

                        Pack sizes and packaging material

                        Bottle: 250-1000 ml
                        packaging material: HDPE, surlyn/PP
                        closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP
                        canister: 5-10 L
                        packaging material: HDPE.
                        closure material is either: HDPE/LDPE
                        Revolver BAG: 1 L
                        packaging material: EVA
                        Closure : PP/Silicone/EVA

                  4.3.1.   Use-specific instructions for use

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

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

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

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

            See general directions for use.
            4.4.   Use description

               Table 10. Use # 4 – Disinfection of surfaces with food and feed contact - wiping

                        Product type

                        PT04 - Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Scientific name: Bacteria including Mycobacterium tuberculosis

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

                        Field(s) of use

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

                        Application method(s)

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

                        Application rate(s) and frequency

                        Ready-to-use. Do not apply more than 25 ml/m2.
                        Disinfection when required according to SOP.

                        Category(ies) of users

                        Industrial
                        Professional

                        Pack sizes and packaging material

                        Bottle: 250-1000 ml
                        packaging material: HDPE, surlyn/PP
                        closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP
                        canister: 5-10 L
                        packaging material: HDPE.
                        closure material is either: HDPE/LDPE
                        Revolver BAG: 1 L
                        packaging material: EVA
                        closure material: PP/Silicone/EVA

                  4.4.1.   Use-specific instructions for use

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

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

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

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

            See general directions for use.
            5.   GENERAL DIRECTIONS FOR USE (3)
               OF THE META SPC 3

            5.1.   Instructions for use

            Clean the surface carefully before use.
            Remove excess water from the surface before disinfection, if appropriate.
            Do not apply more than 25 ml/m2.
            Make sure to wet surfaces completely.
            Used wipes must be disposed in a closed container.
            5.2.   Risk mitigation measures

            The product must only be applied for disinfection of small surfaces.
            Ensure adequate ventilation to prevent the formation of explosive atmospheres.
            Avoid contact with eyes.
            Apply a funnel for refilling.
            Keep out of reach of children and pets.
            Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            First aid:

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

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

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

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

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

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

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

            Shelf-life: 36 months
            Keep container tightly closed.
            Store in a well-ventilated place.
            Protect from sunlight.
            Store at room temperature in the original container.
            6.   OTHER INFORMATION

            The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3

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

                        Trade name(s)

                        mikrozid® classic liquid
                        mikrozid® IPA liquid
                        Surface Disinfection liquid pure

                        Authorisation number

                        EU-0023656-0003 1-3

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        63,1

               META SPC 4

            1.   META SPC 4 ADMINISTRATIVE INFORMATION

            1.1.   Meta SPC 4 identifier

                        Identifier

                        meta SPC 4 mikrozid wipes

                  1.2.   Suffix to the authorisation number

                        Number

                        1-4

                  1.3.   Product type(s)

                        Product type(s)

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

                  2.   META SPC 4 COMPOSITION

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

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        63,1

                        63,1

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

                        Formulation(s)

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

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

                        Hazard statements

                        Highly flammable liquid and vapour.
                        Causes serious eye irritation.
                        May cause drowsiness or dizziness.
                        Repeated exposure may cause skin dryness or cracking.

                        Precautionary statements

                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Keep container tightly closed.
                        Ground and bond container and receiving equipment.
                        Use explosion-proof electrical/ventilating/lighting equipment.
                        Use non-sparking tools.
                        Take action to prevent static discharges.
                        Avoid breathing vapours.
                        Avoid breathing spray.
                        Use only outdoors or in a well-ventilated area.
                        Wear eye protection.
                        IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
                        Call a POISON CENTER or doctor if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        If eye irritation persists: Get medical attention.
                        In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
                        Store in a well-ventilated place. Keep cool.
                        Store locked up.
                        Dispose of contents /container to an approved waste disposal plant.

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

            4.1.   Use description

               Table 11. Use # 1 – Disinfection of surfaces - wiping

                        Product type

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

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Scientific name: Bacteria including Mycobacterium tuberculosis

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

                        Field(s) of use

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

                        Application method(s)

                        Wiping
                        Product will be wiped directly on the surface.

                        Application rate(s) and frequency

                        Ready-to-use wipes
                        Disinfection when required according to SOP.

                        Category(ies) of users

                        Industrial
                        Professional

                        Pack sizes and packaging material

                        Soft pack: 1-200 wipes
                        Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
                        Pouch: 10-200 wipes
                        Packaging material: LDPE/PET
                        Tube: 50-200 wipes
                        Packaging material: HDPE
                        closure material is either PP, PE3385

                  4.1.1.   Use-specific instructions for use

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

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

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

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

            See general directions for use.
            4.2.   Use description

               Table 12. Use # 2 – Disinfection of surfaces with food and feed contact - wiping

                        Product type

                        PT04 - Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Scientific name: Bacteria including Mycobacterium tuberculosis

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

                        Field(s) of use

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

                        Application method(s)

                        Wiping
                        Product will be wiped directly on the surface.

                        Application rate(s) and frequency

                        Ready-to-use wipes
                        Disinfection when required according to SOP.

                        Category(ies) of users

                        Industrial
                        Professional

                        Pack sizes and packaging material

                        Soft pack: 1-200 wipes
                        Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
                        Pouch: 10-200 wipes
                        Packaging material: LDPE/PET
                        Tube: 50-200 wipes
                        Packaging material: HDPE
                        closure material is either PP, PE3385

                  4.2.1.   Use-specific instructions for use

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

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

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

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

            See general directions for use.
            5.   GENERAL DIRECTIONS FOR USE (4)
               OF THE META SPC 4

            5.1.   Instructions for use

            Clean the surface carefully before use.
            Remove excess water from the surface before disinfection, if appropriate.
            Make sure to wet surfaces completely.
            Used wipes must be disposed in a closed container.
            5.2.   Risk mitigation measures

            The product must only be applied for disinfection of small surfaces.
            Ensure adequate ventilation to prevent the formation of explosive atmospheres.
            Avoid contact with eyes.
            Keep out of reach of children and pets.
            Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            First aid:

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

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

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

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

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

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

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

            Shelf-life: 24 months
            Keep container tightly closed.
            Store in a well-ventilated place.
            Protect from sunlight.
            Store at room temperature in the original container.
            6.   OTHER INFORMATION

            The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4

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

                        Trade name(s)

                        mikrozid® classic wipes
                        mikrozid® IPA wipes
                        surface disinfection wipes classic

                        Authorisation number

                        EU-0023656-0004 1-4

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        63,1

               META SPC 5

            1.   META SPC 5 ADMINISTRATIVE INFORMATION

            1.1.   Meta SPC 5 identifier

                        Identifier

                        meta SPC 5 kodan wipes IPA pro

                  1.2.   Suffix to the authorisation number

                        Number

                        1-5

                  1.3.   Product type(s)

                        Product type(s)

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

                  2.   META SPC 5 COMPOSITION

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

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        63,1

                        63,1

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

                        Formulation(s)

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

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

                        Hazard statements

                        Highly flammable liquid and vapour.
                        Causes serious eye irritation.
                        May cause drowsiness or dizziness.
                        Repeated exposure may cause skin dryness or cracking.

                        Precautionary statements

                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Keep container tightly closed.
                        Ground and bond container and receiving equipment.
                        Use explosion-proof electrical/ventilating/lighting equipment.
                        Use non-sparking tools.
                        Take action to prevent static discharges.
                        Avoid breathing vapours.
                        Avoid breathing spray.
                        Use only outdoors or in a well-ventilated area.
                        Wear eye protection.
                        IF IN EYES: Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
                        Call a POISON CENTER or doctor if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        If eye irritation persists: Get medical attention.
                        In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
                        Store in a well-ventilated place. Keep cool.
                        Store locked up.
                        Dispose of contents /container to an approved waste disposal plant.

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

            4.1.   Use description

               Table 13. Use # 1 – Disinfection of surfaces - wiping

                        Product type

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

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Scientific name: Bacteria including Mycobacterium tuberculosis

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

                        Field(s) of use

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

                        Application method(s)

                        Wiping
                        Product will be wiped directly on the surface.

                        Application rate(s) and frequency

                        Ready-to-use wipes

                        Category(ies) of users

                        Industrial
                        Professional

                        Pack sizes and packaging material

                        Soft pack: 1-200 wipes
                        Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
                        Pouch: 10-200 wipes
                        Packaging material: LDPE/PET
                        Tube: 50-200 wipes
                        Packaging material: HDPE
                        closure material is either PP, PE3385

                  4.1.1.   Use-specific instructions for use

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

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

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

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

            See general directions for use.
            4.2.   Use description

               Table 14. Use # 2 – disinfection of surfaces with food and feed contact - wiping

                        Product type

                        PT04 - Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Scientific name: Bacteria including Mycobacterium tuberculosis

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

                        Field(s) of use

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

                        Application method(s)

                        Wiping
                        Product will be wiped directly on the surface.

                        Application rate(s) and frequency

                        Ready-to-use wipes

                        Category(ies) of users

                        Industrial
                        Professional

                        Pack sizes and packaging material

                        Soft pack: 1-200 wipes
                        Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
                        Pouch: 10-200 wipes
                        Packaging material: LDPE/PET
                        Tube: 50-200 wipes
                        Packaging material: HDPE
                        closure material is either PP, PE3385

                  4.2.1.   Use-specific instructions for use

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

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

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

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

            See general directions for use.
            5.   GENERAL DIRECTIONS FOR USE (5)
               OF THE META SPC 5

            5.1.   Instructions for use

            Clean the surface carefully before use.
            Remove excess water from the surface before disinfection, if appropriate.
            Make sure to wet surfaces completely.
            Used wipes must be disposed in a closed container.
            5.2.   Risk mitigation measures

            The product must only be applied for disinfection of small surfaces.
            Ensure adequate ventilation to prevent the formation of explosive atmospheres.
            Avoid contact with eyes.
            Keep out of reach of children and pets.
            Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            First aid:

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

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

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

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

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

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

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

            Shelf-life: 24 months
            Keep container tightly closed.
            Store in a well-ventilated place.
            Protect from sunlight.
            Store at room temperature in the original container.
            6.   OTHER INFORMATION

            The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5

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

                        Trade name(s)

                        kodan® wipes pure
                        schülke® classic wipes

                        Authorisation number

                        EU-0023656-0005 1-5

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        63,1

               META SPC 6

            1.   META SPC 6 ADMINISTRATIVE INFORMATION

            1.1.   Meta SPC 6 identifier

                        Identifier

                        meta SPC 6 kodan wipes IPA

                  1.2.   Suffix to the authorisation number

                        Number

                        1-6

                  1.3.   Product type(s)

                        Product type(s)

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

                  2.   META SPC 6 COMPOSITION

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

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        63,1

                        63,1

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

                        Formulation(s)

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

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6

                        Hazard statements

                        Highly flammable liquid and vapour.
                        Causes serious eye irritation.
                        May cause drowsiness or dizziness.
                        Repeated exposure may cause skin dryness or cracking.

                        Precautionary statements

                        If medical advice is needed, have product container or label at hand.
                        Keep out of reach of children.
                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Keep container tightly closed.
                        Ground and bond container and receiving equipment.
                        Use explosion-proof electrical/ventilating/lighting equipment.
                        Use non-sparking tools.
                        Take action to prevent static discharges.
                        Avoid breathing vapours.
                        Avoid breathing spray.
                        Use only outdoors or in a well-ventilated area.
                        IF INHALED: Remove person to fresh air and keep comfortable for breathing.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        Call a POISON CENTER or doctor if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        If eye irritation persists: Get medical attention.
                        In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
                        Store in a well-ventilated place. Keep cool.
                        Store locked up.
                        Dispose of contents /container to an approved waste disposal plant.

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

            4.1.   Use description

               Table 15. Use # 1 – Disinfection of surfaces - wiping

                        Product type

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

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Scientific name: Bacteria including Mycobacterium tuberculosis

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

                        Field(s) of use

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

                        Application method(s)

                        Wiping
                        Product will be wiped directly on the surface.

                        Application rate(s) and frequency

                        Ready-to-use wipes

                        Category(ies) of users

                        Industrial
                        Professional
                        General public (non-professional)

                        Pack sizes and packaging material

                        Soft pack: 1-200 wipes
                        Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
                        Pouch: 10-200 wipes
                        Packaging material: LDPE/PET
                        Tube: 50-200 wipes
                        Packaging material: HDPE
                        closure material is either PP, PE3385

                  4.1.1.   Use-specific instructions for use

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

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

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

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

            See general directions for use.
            4.2.   Use description

               Table 16. Use # 2 – Disinfection of surfaces with food and feed contact - wiping

                        Product type

                        PT04 - Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Scientific name: Bacteria including Mycobacterium tuberculosis

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

                        Field(s) of use

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

                        Application method(s)

                        Wiping
                        Product will be wiped directly on the surface.

                        Application rate(s) and frequency

                        Ready-to-use wipes

                        Category(ies) of users

                        Industrial
                        Professional
                        General public (non-professional)

                        Pack sizes and packaging material

                        Soft pack: 1-200 wipes
                        Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
                        Pouch: 10-200 wipes
                        Packaging material: LDPE/PET
                        Tube: 50-200 wipes
                        Packaging material: HDPE
                        closure material is either PP, PE3385

                  4.2.1.   Use-specific instructions for use

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

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

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

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

            See general directions for use.
            5.   GENERAL DIRECTIONS FOR USE (6)
               OF THE META SPC 6

            5.1.   Instructions for use

            Clean the surface carefully before use.
            Remove excess water from the surface before disinfection, if appropriate.
            Make sure to wet surfaces completely.
            Used wipes must be disposed in a closed container.
            5.2.   Risk mitigation measures

            The product must only be applied for disinfection of small surfaces.
            Ensure adequate ventilation to prevent the formation of explosive atmospheres.
            Avoid contact with eyes.
            Keep out of the reach of children and pets.
            Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            First aid:

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

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

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

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

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

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

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

            Shelf-life: 24 months
            Keep container tightly closed.
            Store in a well-ventilated place.
            Protect from sunlight.
            Store at room temperature in the original container.
            6.   OTHER INFORMATION

            The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6

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

                        Trade name(s)

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

                        Authorisation number

                        EU-0023656-0006 1-6

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        63,1

               META SPC 7

            1.   META SPC 7 ADMINISTRATIVE INFORMATION

            1.1.   Meta SPC 7 identifier

                        Identifier

                        meta SPC 7 AntiLy SD

                  1.2.   Suffix to the authorisation number

                        Number

                        1-7

                  1.3.   Product type(s)

                        Product type(s)

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

                  2.   META SPC 7 COMPOSITION

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

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        63,1

                        63,1

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

                        Formulation(s)

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

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7

                        Hazard statements

                        Highly flammable liquid and vapour.
                        Causes serious eye irritation.
                        May cause drowsiness or dizziness.
                        Repeated exposure may cause skin dryness or cracking.

                        Precautionary statements

                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Keep container tightly closed.
                        Ground and bond container and receiving equipment.
                        Use explosion-proof electrical/ventilating/lighting equipment.
                        Use non-sparking tools.
                        Take action to prevent static discharges.
                        Avoid breathing vapours.
                        Avoid breathing spray.
                        Use only outdoors or in a well-ventilated area.
                        Wear eye protection.
                        IF IN EYES: Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
                        Call a POISON CENTER or doctor if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        If eye irritation persists: Get medical attention.
                        In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
                        Store in a well-ventilated place. Keep cool.
                        Store locked up.
                        Dispose of contents /container to an approved waste disposal plant.

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

            4.1.   Use description

               Table 17. Use # 1 – Disinfection of surfaces - spraying

                        Product type

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

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

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

                        Field(s) of use

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

                        Application method(s)

                        Spraying
                        Product will be sprayed directly on the surface.

                        Application rate(s) and frequency

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

                        Category(ies) of users

                        Industrial
                        Professional

                        Pack sizes and packaging material

                        Bottle: 125-1000 ml
                        packaging material: HDPE
                        Clack cap material: PP; Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel); Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)

                  4.1.1.   Use-specific instructions for use

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

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

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

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

            See general directions for use.
            4.2.   Use description

               Table 18. Use # 2 – Disinfection of surfaces - wiping

                        Product type

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

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

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

                        Field(s) of use

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

                        Application method(s)

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

                        Application rate(s) and frequency

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

                        Category(ies) of users

                        Industrial
                        Professional

                        Pack sizes and packaging material

                        Bottle: 125-1000 ml
                        packaging material: HDPE
                        Clack cap material: PP
                        Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel);
                        Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)
                        Canister: 5-30 L
                        packaging material: HDPE
                        closure material: HDPE

                  4.2.1.   Use-specific instructions for use

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

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

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

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

            See general directions for use.
            4.3.   Use description

               Table 19. Use # 3 – Disinfection of surfaces with food and feed contact - spraying

                        Product type

                        PT04 - Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

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

                        Field(s) of use

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

                        Application method(s)

                        Spraying
                        Product will be sprayed directly on the surface.

                        Application rate(s) and frequency

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

                        Category(ies) of users

                        Industrial
                        Professional

                        Pack sizes and packaging material

                        Bottle: 125-1000 ml
                        packaging material: HDPE
                        Clack cap material: PP
                        Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
                        Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)

                  4.3.1.   Use-specific instructions for use

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

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

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

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

            See general directions for use.
            4.4.   Use description

               Table 20. Use # 4 – Disinfection of surfaces with food and feed contact - wiping

                        Product type

                        PT04 - Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

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

                        Field(s) of use

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

                        Application method(s)

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

                        Application rate(s) and frequency

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

                        Category(ies) of users

                        Industrial
                        Professional

                        Pack sizes and packaging material

                        Bottle: 125-1000 ml
                        packaging material: HDPE
                        Clack cap material: PP
                        Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
                        Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)
                        Canister: 5-30 L
                        packaging material: HDPE
                        closure material: HDPE

                  4.4.1.   Use-specific instructions for use

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

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

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

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

            See general directions for use.
            5.   GENERAL DIRECTIONS FOR USE (7)
               OF THE META SPC 7

            5.1.   Instructions for use

            Clean the surface carefully before use.
            Remove excess water from the surface before disinfection, if appropriate.
            Do not apply more than 25 ml/m2.
            Make sure to wet surfaces completely.
            Used wipes must be disposed in a closed container.
            5.2.   Risk mitigation measures

            The product must only be applied for disinfection of small surfaces.
            Ensure adequate ventilation to prevent the formation of explosive atmospheres.
            Avoid contact with eyes.
            Apply a funnel for refilling.
            Keep out of reach of children and pets.
            Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            First aid:

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

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

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

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

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

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

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

            Shelf-life: 36 months
            Keep container tightly closed.
            Store in a well-ventilated place.
            Protect from sunlight.
            Store at room temperature in the original container.
            6.   OTHER INFORMATION

            The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7

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

                        Trade name(s)

                        AntiLy 5

                        Authorisation number

                        EU-0023656-0007 1-7

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        63,1

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

                        Trade name(s)

                        AntiLy 6

                        Authorisation number

                        EU-0023656-0008 1-7

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        63,1

               META SPC 8

            1.   META SPC 8 ADMINISTRATIVE INFORMATION

            1.1.   Meta SPC 8 identifier

                        Identifier

                        meta SPC 8 AntiLy SD wipes

                  1.2.   Suffix to the authorisation number

                        Number

                        1-8

                  1.3.   Product type(s)

                        Product type(s)

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

                  2.   META SPC 8 COMPOSITION

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

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        63,1

                        63,1

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

                        Formulation(s)

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

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8

                        Hazard statements

                        Highly flammable liquid and vapour.
                        Causes serious eye irritation.
                        May cause drowsiness or dizziness.
                        Repeated exposure may cause skin dryness or cracking.

                        Precautionary statements

                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Keep container tightly closed.
                        Ground and bond container and receiving equipment.
                        Use explosion-proof electrical/ventilating/lighting equipment.
                        Use non-sparking tools.
                        Take action to prevent static discharges.
                        Avoid breathing vapours.
                        Avoid breathing spray.
                        Use only outdoors or in a well-ventilated area.
                        Wear eye protection.
                        IF IN EYES: Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
                        Call a POISON CENTER or doctor if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        If eye irritation persists: Get medical attention.
                        In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
                        Store in a well-ventilated place. Keep cool.
                        Store locked up.
                        Dispose of contents /container to an approved waste disposal plant.

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

            4.1.   Use description

               Table 21. Use # 1 – Disinfection of surfaces - wiping

                        Product type

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

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

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

                        Field(s) of use

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

                        Application method(s)

                        Wiping
                        Product will be wiped directly on the surface.

                        Application rate(s) and frequency

                        Ready-to-use wipes

                        Category(ies) of users

                        Industrial
                        Professional

                        Pack sizes and packaging material

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

                  4.1.1.   Use-specific instructions for use

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

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

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

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

            See general directions for use.
            4.2.   Use description

               Table 22. Use # 2 – Disinfection of surfaces with food and feed contact - wiping

                        Product type

                        PT04 - Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

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

                        Field(s) of use

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

                        Application method(s)

                        Wiping
                        Product will be wiped directly on the surface.

                        Application rate(s) and frequency

                        Ready-to-use wipes

                        Category(ies) of users

                        Industrial
                        Professional

                        Pack sizes and packaging material

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

                  4.2.1.   Use-specific instructions for use

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

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

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

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

            See general directions for use.
            5.   GENERAL DIRECTIONS FOR USE (8)
               OF THE META SPC 8

            5.1.   Instructions for use

            Clean the surface carefully before use.
            Remove excess water from the surface before disinfection, if appropriate.
            Make sure to wet surfaces completely.
            Used wipes must be disposed in a closed container.
            5.2.   Risk mitigation measures

            The product must only be applied for disinfection of small surfaces.
            Ensure adequate ventilation to prevent the formation of explosive atmospheres.
            Avoid contact with eyes.
            Keep out of reach of children and pets.
            Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            First aid:

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

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

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

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

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

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

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

            Shelf-life: 24 months
            Keep container tightly closed.
            Store in a well-ventilated place.
            Protect from sunlight.
            Store at room temperature in the original container.
            6.   OTHER INFORMATION

            The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8

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

                        Trade name(s)

                        AntiLy 5 wipes

                        Authorisation number

                        EU-0023656-0009 1-8

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        63,1

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

                        Trade name(s)

                        AntiLy 6 wipes

                        Authorisation number

                        EU-0023656-0010 1-8

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        63,1

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

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

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

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

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

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

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

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