CELEX: 32021R0978
Language: en
Date: 2021-06-10 00:00:00
Title: Commission Implementing Regulation (EU) 2021/978 of 10 June 2021 granting a Union authorisation for the biocidal product family “Lyso IPA Surface Disinfection” (Text with EEA relevance)

18.6.2021   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 216/65
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2021/978
         of 10 June 2021
         granting a Union authorisation for the biocidal product family “Lyso IPA Surface Disinfection”
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the first subparagraph of Article 44(5) thereof,
         Whereas:
         
                     (1)
                  
                  
                     On 22 June 2016, Schuelke & Mayr GmbH submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for authorisation of the same biocidal product family, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named “Lyso IPA Surface Disinfection”, of product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-GX025200-35 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference product family “perform-IPA”, recorded in the Register under case number BC-AB023095-72.
                  
               
                     (2)
                  
                  
                     The same biocidal product family “Lyso IPA Surface Disinfection” contains propan-2-ol, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012.
                  
               
                     (3)
                  
                  
                     On 12 May 2020, the Agency submitted to the Commission an opinion (3) and the draft summary of the biocidal product characteristics (‘SPC’) of “Lyso IPA Surface Disinfection” in accordance with Article 6(1) and (2) of Implementing Regulation (EU) No 414/2013.
                  
               
                     (4)
                  
                  
                     The opinion concludes that “Lyso IPA Surface Disinfection” is a biocidal product family within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, that the proposed differences between the same biocidal product family and the related reference biocidal product family are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (4), that “Lyso IPA Surface Disinfection” is eligible for Union authorisation in accordance with Article 42(1) of Regulation (EU) No 528/2012, and that based on the assessment of the related reference “perform-IPA” product family and subject to compliance with the draft SPC, the same biocidal product family meets the conditions laid down in Article 19(1) and (6) of Regulation (EU) No 528/2012.
                  
               
                     (5)
                  
                  
                     On 6 November 2020, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.
                  
               
                     (6)
                  
                  
                     The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same biocidal product family “Lyso IPA Surface Disinfection”.
                  
               
                     (7)
                  
                  
                     The same biocidal product family “Lyso IPA Surface Disinfection” contains the non-active substance diethyl phthalate, for which it was not possible to conclude whether it meets the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100 (5) within the period for the evaluation of the application for the related reference biocidal product family. Further examination of diethyl phthalate should therefore take place. If it is concluded that diethyl phthalate is considered as having endocrine-disrupting properties, the Commission will consider whether to cancel or amend the Union authorisation for “Lyso IPA Surface Disinfection” in accordance with Article 48 of Regulation (EU) No 528/2012.
                  
               
                     (8)
                  
                  
                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
                  
               HAS ADOPTED THIS REGULATION:
         
            Article 1
            A Union authorisation with authorisation number EU-0023860-0000 is granted to Schuelke & Mayr GmbH for the making available on the market and use of the same biocidal product family “Lyso IPA Surface Disinfection” in accordance with the summary of the biocidal product characteristics set out in the Annex.
            The Union authorisation is valid from 8 July 2021 until 30 November 2030.
         
         
            Article 2
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
         
         
            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 10 June 2021.
            
               
                  For the Commission
               
               
                  The President
               
               Ursula VON DER LEYEN
            
         
         
            (1)  OJ L 167, 27.6.2012, p. 1.
         
            (2)  Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4).
         
            (3)  ECHA opinion of 11 May 2020 on the Union authorisation of the same biocidal product family “Lyso IPA Surface Disinfection”, https://echa.europa.eu/en/opinions-on-union-authorisation
         
            (4)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4).
         
            (5)  Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1).
      
      
         
            ANNEX
            Summary of product characteristics for a biocidal product family
            Lyso IPA Surface Disinfection
            Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
            Product type 4 – Food and feed area (Disinfectants)
            Authorisation number: EU-0023860-0000
            R4BP asset number: EU-0023860-0000
            PART I
            
               FIRST INFORMATION LEVEL
            
            1.   ADMINISTRATIVE INFORMATION
            
            1.1.   Family name
            
            
                        Name
                     
                     
                        Lyso IPA Surface Disinfection
                     
                  1.2.   Product type(s)
            
            
                        Product type(s)
                     
                     
                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                        PT04 – Food and feed area (Disinfectants)
                     
                  1.3.   Authorisation holder
            
            
                        Name and address of the authorisation holder
                     
                     
                        Name
                     
                     
                        Schülke & Mayr GmbH
                     
                  
                        Address
                     
                     
                        Robert-Koch-Str. 2, 22851, Norderstedt, Germany
                     
                  
                        Authorisation number
                     
                     
                        EU-0023860-0000
                     
                  
                        
                           R4BP asset number
                        
                     
                     
                        EU-0023860-0000
                     
                  
                        Date of the authorisation
                     
                     
                        8 July 2021
                     
                  
                        Expiry date of the authorisation
                     
                     
                        30 November 2030
                     
                  1.4.   Manufacturer(s) of the biocidal products
            
            
                        Name of manufacturer
                     
                     
                        Schülke & Mayr GmbH
                     
                  
                        Address of manufacturer
                     
                     
                        Robert-Koch-Str. 2, 22851 Norderstedt Germany
                     
                  
                        Location of manufacturing sites
                     
                     
                        Robert-Koch-Str. 2, 22851 Norderstedt Germany
                     
                  
               
            
                        Name of manufacturer
                     
                     
                        BOCHEMIE a.s.
                     
                  
                        Address of manufacturer
                     
                     
                        Lidická 326, 735 95 Bohumín Czech Republic
                     
                  
                        Location of manufacturing sites
                     
                     
                        Lidická 326, 735 95 Bohumín Czech Republic
                     
                  
               
            
                        Name of manufacturer
                     
                     
                        Imeco
                     
                  
                        Address of manufacturer
                     
                     
                        Boschstr. 5, 63768 Hösbach Germany
                     
                  
                        Location of manufacturing sites
                     
                     
                        Boschstr. 5, 63768 Hösbach Germany
                        Neue Straße 2-4, 09471 Köningswalde Germany
                     
                  
               
            
                        Name of manufacturer
                     
                     
                        Tristel Solutions Limited
                     
                  
                        Address of manufacturer
                     
                     
                        Lynx Business Park, Fordham Road, Snailwell, CB8 7NY Cambridgeshire United Kingdom
                     
                  
                        Location of manufacturing sites
                     
                     
                        Lynx Business Park, Fordham Road, Snailwell, CB8 7NY Cambridgeshire United Kingdom
                     
                  
               
            
                        Name of manufacturer
                     
                     
                        Techtex
                     
                  
                        Address of manufacturer
                     
                     
                        Units 7&8 Rhodes Bus. Park Silburn Way, M24 4NE Middleton United Kingdom
                     
                  
                        Location of manufacturing sites
                     
                     
                        Units 7&8 Rhodes Bus. Park Silburn Way, M24 4NE Middleton United Kingdom
                     
                  
               
            
                        Name of manufacturer
                     
                     
                        A.F.P. GmbH
                     
                  
                        Address of manufacturer
                     
                     
                        Otto Brenner Straße 16, 21337 Lüneburg Germany
                     
                  
                        Location of manufacturing sites
                     
                     
                        Otto Brenner Straße 16, 21337 Lüneburg Germany
                     
                  
               
            
                        Name of manufacturer
                     
                     
                        Innovate GmbH
                     
                  
                        Address of manufacturer
                     
                     
                        Am Hohen Stein 11, 06618 Naumbourg (Saale) Germany
                     
                  
                        Location of manufacturing sites
                     
                     
                        Am Hohen Stein 11, 06618 Naumbourg (Saale) Germany
                     
                  
               
            
                        Name of manufacturer
                     
                     
                        Lysoform Dr. Hans Rosemann GmbH
                     
                  
                        Address of manufacturer
                     
                     
                        Kaiser-Wilhelm-Straße 133, 12247 Berlin Germany
                     
                  
                        Location of manufacturing sites
                     
                     
                        Kaiser-Wilhelm-Straße 133, 12247 Berlin Germany
                     
                  
               
            
                        Name of manufacturer
                     
                     
                        Sterisol AB
                     
                  
                        Address of manufacturer
                     
                     
                        Kronoängsgatan 3, 592 23 Vadstena Sweden
                     
                  
                        Location of manufacturing sites
                     
                     
                        Kronoängsgatan 3, 592 23 Vadstena Sweden
                     
                  
               
            
                        Name of manufacturer
                     
                     
                        Rudolf Dankwardt GmbH
                     
                  
                        Address of manufacturer
                     
                     
                        Gutenbergring 50-52, 22848 Norderstedt Germany
                     
                  
                        Location of manufacturing sites
                     
                     
                        Gutenbergring 50-52, 22848 Norderstedt Germany
                        Lagerstr. 15, 19249 Jessenitz - Werk/Lübtheen Germany
                     
                  1.5.   Manufacturer(s) of the active substance(s)
            
            
                        Active substance
                     
                     
                        Propan-2-ol
                     
                  
                        Name of manufacturer
                     
                     
                        Ineos Solvents Germany GmbH (formerly Sasol)
                     
                  
                        Address of manufacturer
                     
                     
                        Römerstraße 733, 47443 Moers Germany
                     
                  
                        Location of manufacturing sites
                     
                     
                        Römerstraße 733, 47443 Moers Germany
                        Shamrockstr. 88, 44643 Herne Germany
                     
                  
               
            
                        Active substance
                     
                     
                        Propan-2-ol
                     
                  
                        Name of manufacturer
                     
                     
                        Shell Chemicals Europe B.V.
                     
                  
                        Address of manufacturer
                     
                     
                        Postbus 2334, 3000 CH Rotterdam Netherlands
                     
                  
                        Location of manufacturing sites
                     
                     
                        Shell Nederland Raffinaderij B.V., Vondelingenweg 601, 3196 KK Rotterdam-Pernis Netherlands
                     
                  2.   PRODUCT FAMILY COMPOSITION AND FORMULATION
            
            2.1.   Qualitative and quantitative information on the composition of the family
            
            
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Min
                     
                     
                        Max
                     
                  
                        Propan-2-ol
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        67-63-0
                     
                     
                        200-661-7
                     
                     
                        63,1
                     
                     
                        63,1
                     
                  2.2.   Type(s) of formulation
            
            
                        Formulation(s)
                     
                     
                        Any other liquid (AL), ready-to-use
                        Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation
                     
                  PART II
            
               SECOND INFORMATION LEVEL – META SPC(S)
            
            
               META SPC 1
            
            1.   META SPC 1 ADMINISTRATIVE INFORMATION
            
            1.1.   Meta SPC 1 identifier
            
            
                        Identifier
                     
                     
                        meta-SPC1
                     
                  1.2.   Suffix to the authorisation number
            
            
                        Number
                     
                     
                        1-1
                     
                  1.3.   Product type(s)
            
            
                        Product type(s)
                     
                     
                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                        PT04 – Food and feed area (Disinfectants)
                     
                  2.   META SPC 1 COMPOSITION
            
            2.1.   Qualitative and quantitative information on the composition of the meta SPC 1
            
            
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Min
                     
                     
                        Max
                     
                  
                        Propan-2-ol
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        67-63-0
                     
                     
                        200-661-7
                     
                     
                        63,1
                     
                     
                        63,1
                     
                  2.2.   Type(s) of formulation of the meta SPC 1
            
            
                        Formulation(s)
                     
                     
                        Any other liquid (AL), ready-to-use
                     
                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
            
            
                        Hazard statements
                     
                     
                        Highly flammable liquid and vapour.
                        Causes serious eye irritation.
                        May cause drowsiness or dizziness.
                        Repeated exposure may cause skin dryness or cracking.
                     
                  
                        Precautionary statements
                     
                     
                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Keep container tightly closed.
                        Ground and bond container and receiving equipment.
                        Use explosion-proof electrical/ventilating/lighting equipment.
                        Use non-sparking tools.
                        Take action to prevent static discharges.
                        Avoid breathing vapours.
                        Avoid breathing spray.
                        Use only outdoors or in a well-ventilated area.
                        Wear eye protection.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        Call a POISON CENTER or doctor if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        If eye irritation persists: Get medical attention.
                        In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
                        Store in a well-ventilated place. Keep cool.
                        Store locked up.
                        Dispose of contents/container to an approved waste disposal plant.
                     
                  4.   AUTHORISED USE(S) OF THE META SPC 1
            
            4.1.   Use description
            
            
               Table 1. Use # 1 – Disinfection of surfaces – spraying
            
            
                        Product type
                     
                     
                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Scientific name: Bacteria
                        Common name: -
                        Development stage: -
                        Scientific name: Yeast
                        Common name: -
                        Development stage: -
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)
                     
                  
                        Application method(s)
                     
                     
                        Spraying
                        Product will be sprayed directly on the surface
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Ready-to-use. Do not apply more than 25 ml/m2.
                        Disinfection after each production and cleaning process or when required according to standard operating procedure (SOP)
                     
                  
                        Category(ies) of users
                     
                     
                        Industrial
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Bottle: 250-1000 ml
                        packaging material: high-density polyethylene (HDPE), surlyn/polypropylene (PP)
                        closure material is either: PP, polyoxymethylene (POM), low-density polyethylene (LDPE), HDPE, polyethylene (PE), ethylene-vinyl acetate (EVA), stainless steel, polybutylene terephthalate (PBT), (LD)PE, exp. polytetrafluoroethylene (PTFE), linear low density polyethylene (LLDPE), expanded PE (EXPPE), Co Polymer PP
                        canister: 5-10 L
                        packaging material: HDPE.
                        closure material is either: HDPE/LDPE
                        Revolver BAG: 1 L
                        packaging material: EVA
                        closure material: PP/Silicone/EVA
                     
                  4.1.1.   Use-specific instructions for use
            
            Spray ready-to-use product on the surface and allow to take effect at room temperature (20 ± 2 °C) for at least 1 minute.
            4.1.2.   Use-specific risk mitigation measures
            
            The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use.
            4.2.   Use description
            
            
               Table 2. Use # 2 – Disinfection of surfaces – wiping
            
            
                        Product type
                     
                     
                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Scientific name: Bacteria
                        Common name: -
                        Development stage: -
                        Scientific name: Yeast
                        Common name: -
                        Development stage: -
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)
                     
                  
                        Application method(s)
                     
                     
                        Wiping
                        Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on the surface.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Ready-to-use. Do not apply more than 25 ml/m2.
                        Disinfection after each production and cleaning process or when required according to SOP.
                     
                  
                        Category(ies) of users
                     
                     
                        Industrial
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Bottle: 250-1000 ml
                        packaging material: HDPE, surlyn/PP
                        closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP.
                        canister: 5-10 L
                        packaging material: HDPE.
                        closure material is either: HDPE/LDPE
                        Revolver BAG: 1 L
                        packaging material: EVA
                        closure material: PP/Silicone/EVA.
                     
                  4.2.1.   Use-specific instructions for use
            
            Spray or pour ready-to-use product on the surface and wipe afterwards or wet a wipe with the ready-to-use product by spraying or pouring and thereafter wipe the surface. Allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).
            4.2.2.   Use-specific risk mitigation measures
            
            The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
            4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use.
            4.3.   Use description
            
            
               Table 3. Use # 3 – Disinfection of surfaces with food and feed contact – spraying
            
            
                        Product type
                     
                     
                        PT04 – Food and feed area (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Scientific name: Bacteria
                        Common name: -
                        Development stage: -
                        Scientific name: Yeast
                        Common name: -
                        Development stage: -
                        Scientific name: Viruses
                        Common name: -
                        Development stage: -
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
                     
                  
                        Application method(s)
                     
                     
                        Spraying
                        Product will be sprayed directly on the surface.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Ready-to-use. Do not apply more than 25 ml/m2.
                        Disinfection after each production and cleaning process or when required according to SOP.
                     
                  
                        Category(ies) of users
                     
                     
                        Industrial
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Bottle: 250-1000 ml
                        packaging material: HDPE, surlyn/PP
                        closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP.
                        canister: 5-10 L
                        packaging material: HDPE.
                        closure material is either: HDPE/LDPE
                        Revolver BAG: 1 L
                        packaging material: EVA
                        closure material: PP/Silicone/EVA.
                     
                  4.3.1.   Use-specific instructions for use
            
            Spray ready-to-use product on the surface and allow to take effect at room temperature (20 ± 2 °C) for at least 1 minute (bactericidal and yeasticidal activity) or 2 minutes (virucidal activity).
            4.3.2.   Use-specific risk mitigation measures
            
            The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product.
            4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            -
            4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use.
            4.4.   Use description
            
            
               Table 4. Use # 4 – Disinfection of surfaces with food and feed contact – wiping
            
            
                        Product type
                     
                     
                        PT04 – Food and feed area (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Scientific name: Bacteria
                        Common name: -
                        Development stage: -
                        Scientific name: Yeast
                        Common name: -
                        Development stage: -
                        Scientific name: Viruses
                        Common name: -
                        Development stage: -
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
                     
                  
                        Application method(s)
                     
                     
                        Wiping
                        Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on the surface.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Ready-to-use. Do not apply more than 25 ml/m2.
                        Disinfection after each production and cleaning process or when required according to SOP.
                     
                  
                        Category(ies) of users
                     
                     
                        Industrial
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Bottle: 250-1000 ml
                        packaging material: HDPE, surlyn/PP
                        closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP.
                        canister: 5-10 L
                        packaging material: HDPE.
                        closure material is either: HDPE/LDPE
                        Revolver BAG: 1 L
                        packaging material: EVA
                        closure material: PP/Silicone/EVA.
                     
                  4.4.1.   Use-specific instructions for use
            
            Spray ready-to-use product on the surface and wipe afterwards or wet a wipe with the ready-to-use product by spraying or pouring and thereafter wipe the surface. Allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).
            4.4.2.   Use-specific risk mitigation measures
            
            The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures:
            Wear eye protection during handling of the product.
            4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            -
            4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use.
            5.   GENERAL DIRECTIONS FOR USE (1)
               OF THE META SPC 1
            
            5.1.   Instructions for use
            
            Clean the surface carefully before use.
            Remove excess water from the surface before disinfection, if appropriate.
            Do not apply more than 25 ml/m2.
            Make sure to wet surfaces completely.
            Used wipes must be disposed in a closed container.
            5.2.   Risk mitigation measures
            
            The product must only be applied for disinfection of small surfaces.
            Ensure adequate ventilation to prevent the formation of explosive atmospheres.
            Avoid contact with eyes.
            Apply a funnel for refilling.
            Keep out of reach of children and pets.
            Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            First aid:
            
                         
                     
                     
                        In case of accident: Call a poison centre or a doctor.
                     
                  
                         
                     
                     
                        IF INHALED: Remove person to fresh air and keep comfortable for breathing.
                     
                  
                         
                     
                     
                        If on skin: Wash with water. If skin irritation occurs: Get medical advice.
                     
                  
                         
                     
                     
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
                     
                  
                         
                     
                     
                        IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
                     
                  5.4.   Instructions for safe disposal of the product and its packaging
            
            -
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage
            
            Shelf-life: 36 months
            Keep container tightly closed.
            Store in a well-ventilated place.
            Protect from sunlight.
            Store at room temperature in the original container.
            6.   OTHER INFORMATION
            
            The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
            
            7.1.   Trade name(s), authorisation number and specific composition of each individual product
            
            
                        Trade name(s)
                     
                     
                        Schülke® 6
                     
                     
                        Market area: EU
                     
                  
                        Authorisation number
                     
                     
                        EU-0023860-0001 1-1
                     
                  
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Propan-2-ol
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        67-63-0
                     
                     
                        200-661-7
                     
                     
                        63,1
                     
                  
               META SPC 2
            
            1.   META SPC 2 ADMINISTRATIVE INFORMATION
            
            1.1.   Meta SPC 2 identifier
            
            
                        Identifier
                     
                     
                        meta-SPC 2
                     
                  1.2.   Suffix to the authorisation number
            
            
                        Number
                     
                     
                        1-2
                     
                  1.3.   Product type(s)
            
            
                        Product type(s)
                     
                     
                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                        PT04 – Food and feed area (Disinfectants)
                     
                  2.   META SPC 2 COMPOSITION
            
            2.1.   Qualitative and quantitative information on the composition of the meta SPC 2
            
            
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Min
                     
                     
                        Max
                     
                  
                        Propan-2-ol
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        67-63-0
                     
                     
                        200-661-7
                     
                     
                        63,1
                     
                     
                        63,1
                     
                  2.2.   Type(s) of formulation of the meta SPC 2
            
            
                        Formulation(s)
                     
                     
                        Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation
                     
                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
            
            
                        Hazard statements
                     
                     
                        Highly flammable liquid and vapour.
                        Causes serious eye irritation.
                        May cause drowsiness or dizziness.
                        Repeated exposure may cause skin dryness or cracking.
                     
                  
                        Precautionary statements
                     
                     
                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Keep container tightly closed.
                        Ground and bond container and receiving equipment.
                        Use explosion-proof electrical/ventilating/lighting equipment.
                        Use non-sparking tools.
                        Take action to prevent static discharges.
                        Avoid breathing vapours.
                        Avoid breathing spray.
                        Use only outdoors or in a well-ventilated area.
                        Wear eye protection.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        Call a POISON CENTER or doctor if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        If eye irritation persists: Get medical attention.
                        In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
                        Store in a well-ventilated place. Keep cool.
                        Store locked up.
                        Dispose of contents/container to an approved waste disposal plant.
                     
                  4.   AUTHORISED USE(S) OF THE META SPC 2
            
            4.1.   Use description
            
            
               Table 5. Use # 1 – Disinfection of surfaces – wiping
            
            
                        Product type
                     
                     
                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Scientific name: Bacteria
                        Common name: -
                        Development stage: -
                        Scientific name: Yeast
                        Common name: -
                        Development stage: -
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)
                     
                  
                        Application method(s)
                     
                     
                        Wiping
                        Product will be wiped directly on the surface.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Ready-to-use wipes
                        Disinfection after each production and cleaning process or when required according to SOP.
                     
                  
                        Category(ies) of users
                     
                     
                        Industrial
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Soft pack: 1-200 wipes
                        Packaging material: LDPE/Alu/PET; LDPE/PET; biaxially oriented polypropylene (BOPP) + cast polypropylene (CPP)
                        Pouch: 10-200 wipes
                        Packaging material: LDPE/PET
                        Tub: 50-200 wipes
                        Packaging material: HDPE
                        Closure material is either PP, PE3385
                     
                  4.1.1.   Use-specific instructions for use
            
            Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).
            4.1.2.   Use-specific risk mitigation measures
            
            See general directions for use.
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            -
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use.
            4.2.   Use description
            
            
               Table 6. Use # 2 – Disinfection of surfaces with food and feed contact – wiping
            
            
                        Product type
                     
                     
                        PT04 – Food and feed area (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Scientific name: Bacteria
                        Common name: -
                        Development stage: -
                        Scientific name: Yeast
                        Common name: -
                        Development stage: -
                        Scientific name: Viruses
                        Common name: -
                        Development stage: -
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
                     
                  
                        Application method(s)
                     
                     
                        Wiping
                        Product will be wiped directly on the surface.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Ready-to-use wipes
                        Disinfection after each production and cleaning process or when required according to SOP.
                     
                  
                        Category(ies) of users
                     
                     
                        Industrial
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Soft pack: 1-200 wipes
                        Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
                        Pouch: 10-200 wipes
                        Packaging material: LDPE/PET
                        Tub: 50-200 wipes
                        Packaging material: HDPE
                        closure material is either PP, PE3385
                     
                  4.2.1.   Use-specific instructions for use
            
            Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).
            4.2.2.   Use-specific risk mitigation measures
            
            See general directions for use.
            4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            -
            4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use.
            5.   GENERAL DIRECTIONS FOR USE (2)
               OF THE META SPC 2
            
            5.1.   Instructions for use
            
            Clean the surface carefully before use.
            Remove excess water from the surface before disinfection, if appropriate.
            Make sure to wet surfaces completely.
            Used wipes must be disposed in a closed container.
            5.2.   Risk mitigation measures
            
            The product must only be applied for disinfection of small surfaces.
            Ensure adequate ventilation to prevent the formation of explosive atmospheres.
            Avoid contact with eyes.
            Keep out of reach of children and pets.
            Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            First aid:
            
                         
                     
                     
                        In case of accident: Call a poison centre or a doctor.
                     
                  
                         
                     
                     
                        IF INHALED: Remove person to fresh air and keep comfortable for breathing.
                     
                  
                         
                     
                     
                        If on skin: Wash with water. If skin irritation occurs: Get medical advice.
                     
                  
                         
                     
                     
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
                     
                  
                         
                     
                     
                        IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
                     
                  5.4.   Instructions for safe disposal of the product and its packaging
            
            -
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage
            
            Shelf-life: 24 months
            Keep container tightly closed.
            Store in a well-ventilated place.
            Protect from sunlight.
            Store at room temperature in the original container.
            6.   OTHER INFORMATION
            
            The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
            
            7.1.   Trade name(s), authorisation number and specific composition of each individual product
            
            
                        Trade name(s)
                     
                     
                        Schülke® 7
                     
                     
                        Market area: EU
                     
                  
                        Authorisation number
                     
                     
                        EU-0023860-0002 1-2
                     
                  
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Propan-2-ol
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        67-63-0
                     
                     
                        200-661-7
                     
                     
                        63,1
                     
                  
               META SPC 3
            
            1.   META SPC 3 ADMINISTRATIVE INFORMATION
            
            1.1.   Meta SPC 3 identifier
            
            
                        Identifier
                     
                     
                        meta-SPC 3
                     
                  1.2.   Suffix to the authorisation number
            
            
                        Number
                     
                     
                        1-3
                     
                  1.3.   Product type(s)
            
            
                        Product type(s)
                     
                     
                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                        PT04 – Food and feed area (Disinfectants)
                     
                  2.   META SPC 3 COMPOSITION
            
            2.1.   Qualitative and quantitative information on the composition of the meta SPC 3
            
            
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Min
                     
                     
                        Max
                     
                  
                        Propan-2-ol
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        67-63-0
                     
                     
                        200-661-7
                     
                     
                        63,1
                     
                     
                        63,1
                     
                  2.2.   Type(s) of formulation of the meta SPC 3
            
            
                        Formulation(s)
                     
                     
                        Any other liquid (AL), ready-to-use
                     
                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
            
            
                        Hazard statements
                     
                     
                        Highly flammable liquid and vapour.
                        Causes serious eye irritation.
                        May cause drowsiness or dizziness.
                        Repeated exposure may cause skin dryness or cracking.
                     
                  
                        Precautionary statements
                     
                     
                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Keep container tightly closed.
                        Ground and bond container and receiving equipment.
                        Use explosion-proof electrical/ventilating/lighting equipment.
                        Use non-sparking tools.
                        Take action to prevent static discharges.
                        Avoid breathing vapours.
                        Avoid breathing spray.
                        Use only outdoors or in a well-ventilated area.
                        Wear eye protection.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        Call a POISON CENTER or doctor if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        If eye irritation persists: Get medical attention.
                        In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
                        Store in a well-ventilated place. Keep cool.
                        Store locked up.
                        Dispose of contents/container to an approved waste disposal plant.
                     
                  4.   AUTHORISED USE(S) OF THE META SPC 3
            
            4.1.   Use description
            
            
               Table 7. Use # 1 – disinfection of surfaces – spraying
            
            
                        Product type
                     
                     
                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Scientific name: Bacteria including Mycobacterium tuberculosis
                        Common name: -
                        Development stage: -
                        Scientific name: Yeast
                        Common name: -
                        Development stage: -
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)
                     
                  
                        Application method(s)
                     
                     
                        Spraying
                        Product will be sprayed directly on the surface
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Ready-to-use. Do not apply more than 25 ml/m2.
                        Disinfection when required according to SOP.
                     
                  
                        Category(ies) of users
                     
                     
                        Industrial
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Bottle: 250-1000 ml
                        packaging material: HDPE, surlyn/PP
                        closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP
                        canister: 5-10 L
                        packaging material: HDPE.
                        closure material is either: HDPE/LDPE
                        Revolver BAG: 1 L
                        packaging material: EVA
                        Closure: PP/Silicone/EVA
                     
                  4.1.1.   Use-specific instructions for use
            
            Spray ready-to-use product on the surface and allow to take effect at room temperature (20 ± 2 °C) for at least 1 minute.
            4.1.2.   Use-specific risk mitigation measures
            
            The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures:
            Wear eye protection during handling of the product.
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            -
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use
            4.2.   Use description
            
            
               Table 8. Use # 2 – Disinfection of surfaces – wiping
            
            
                        Product type
                     
                     
                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Scientific name: Bacteria including Mycobacterium tuberculosis
                        Common name: -
                        Development stage: -
                        Scientific name: Yeast
                        Common name: -
                        Development stage: -
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)
                     
                  
                        Application method(s)
                     
                     
                        Wiping
                        Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on the surface.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Ready-to-use. Do not apply more than 25 ml/m2.
                        Disinfection when required according to SOP.
                     
                  
                        Category(ies) of users
                     
                     
                        Industrial
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Bottle: 250-1000 ml
                        packaging material: HDPE, surlyn/PP
                        closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP
                        canister: 5-10 L
                        packaging material: HDPE.
                        closure material is either: HDPE/LDPE
                        Revolver BAG: 1 L
                        packaging material: EVA
                        Closure: PP/Silicone/EVA
                     
                  4.2.1.   Use-specific instructions for use
            
            Spray or pour ready-to-use product on the surface and wipe afterwards or wet a wipe with the ready-to-use product by spraying or pouring and thereafter wipe the surface. Allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).
            4.2.2.   Use-specific risk mitigation measures
            
            The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures:
            Wear eye protection during handling of the product.
            4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            -
            4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use
            4.3.   Use description
            
            
               Table 9. Use # 3 – Disinfection of surfaces with food and feed contact – spraying
            
            
                        Product type
                     
                     
                        PT04 – Food and feed area (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Scientific name: Bacteria including Mycobacterium tuberculosis
                        Common name: -
                        Development stage: -
                        Scientific name: Yeast
                        Common name: -
                        Development stage: -
                        Scientific name: Viruses
                        Common name: -
                        Development stage: -
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
                     
                  
                        Application method(s)
                     
                     
                        Spraying
                        Product will be sprayed directly on the surface.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Ready-to-use. Do not apply more than 25 ml/m2.
                        Disinfection when required according to SOP.
                     
                  
                        Category(ies) of users
                     
                     
                        Industrial
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Bottle: 250-1000 ml
                        packaging material: HDPE, surlyn/PP
                        closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP
                        canister: 5-10 L
                        packaging material: HDPE.
                        closure material is either: HDPE/LDPE
                        Revolver BAG: 1 L
                        packaging material: EVA
                        Closure: PP/Silicone/EVA
                     
                  4.3.1.   Use-specific instructions for use
            
            Spray ready-to-use product on the surface and allow to take effect at room temperature (20 ± 2 °C) for at least 1 minute (bactericidal and yeasticidal activity) or 2 minutes (virucidal activity).
            4.3.2.   Use-specific risk mitigation measures
            
            The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures:
            Wear eye protection during handling of the product.
            4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            -
            4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use
            4.4.   Use description
            
            
               Table 10. Use # 4 – Disinfection of surfaces with food and feed contact – wiping
            
            
                        Product type
                     
                     
                        PT04 – Food and feed area (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Scientific name: Bacteria including Mycobacterium tuberculosis
                        Common name: -
                        Development stage: -
                        Scientific name: Yeast
                        Common name: -
                        Development stage: -
                        Scientific name: Viruses
                        Common name: -
                        Development stage: -
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
                     
                  
                        Application method(s)
                     
                     
                        Wiping
                        Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on surface.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Ready-to-use. Do not apply more than 25 ml/m2.
                        Disinfection when required according to SOP.
                     
                  
                        Category(ies) of users
                     
                     
                        Industrial
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Bottle: 250-1000 ml
                        packaging material: HDPE, surlyn/PP
                        closure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP
                        canister: 5-10 L
                        packaging material: HDPE.
                        closure material is either: HDPE/LDPE
                        Revolver BAG: 1 L
                        packaging material: EVA
                        Closure: PP/Silicone/EVA
                     
                  4.4.1.   Use-specific instructions for use
            
            Spray or pour ready-to-use product on the surface and wipe afterwards or wet a wipe with the ready-to-use product by spraying or pouring and thereafter wipe the surface. Allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).
            4.4.2.   Use-specific risk mitigation measures
            
            The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures:
            Wear eye protection during handling of the product.
            4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            -
            4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use
            5.   GENERAL DIRECTIONS FOR USE (3)
               OF THE META SPC 3
            
            5.1.   Instructions for use
            
            Clean the surface carefully before use.
            Remove excess water from the surface before disinfection, if appropriate.
            Do not apply more than 25 ml/m2.
            Make sure to wet surfaces completely.
            Used wipes must be disposed in a closed container.
            5.2.   Risk mitigation measures
            
            The product must only be applied for disinfection of small surfaces.
            Ensure adequate ventilation to prevent the formation of explosive atmospheres.
            Avoid contact with eyes.
            Apply a funnel for refilling.
            Keep out of reach of children and pets.
            Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            First aid:
            
                         
                     
                     
                        In case of accident: Call a poison centre or a doctor.
                     
                  
                         
                     
                     
                        IF INHALED: Remove person to fresh air and keep comfortable for breathing.
                     
                  
                         
                     
                     
                        If on skin: Wash with water. If skin irritation occurs: Get medical advice.
                     
                  
                         
                     
                     
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
                     
                  
                         
                     
                     
                        IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
                     
                  5.4.   Instructions for safe disposal of the product and its packaging
            
            -
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage
            
            Shelf-life: 36 months
            Keep container tightly closed.
            Store in a well-ventilated place.
            Protect from sunlight.
            Store at room temperature in the original container.
            6.   OTHER INFORMATION
            
            The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
            
            7.1.   Trade name(s), authorisation number and specific composition of each individual product
            
            
                        Trade name(s)
                     
                     
                        Schülke® 8
                     
                     
                        Market area: EU
                     
                  
                        Authorisation number
                     
                     
                        EU-0023860-0003 1-3
                     
                  
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Propan-2-ol
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        67-63-0
                     
                     
                        200-661-7
                     
                     
                        63,1
                     
                  
               META SPC 4
            
            1.   META SPC 4 ADMINISTRATIVE INFORMATION
            
            1.1.   Meta SPC 4 identifier
            
            
                        Identifier
                     
                     
                        meta-SPC 4
                     
                  1.2.   Suffix to the authorisation number
            
            
                        Number
                     
                     
                        1-4
                     
                  1.3.   Product type(s)
            
            
                        Product type(s)
                     
                     
                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                        PT04 – Food and feed area (Disinfectants)
                     
                  2.   META SPC 4 COMPOSITION
            
            2.1.   Qualitative and quantitative information on the composition of the meta SPC 4
            
            
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Min
                     
                     
                        Max
                     
                  
                        Propan-2-ol
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        67-63-0
                     
                     
                        200-661-7
                     
                     
                        63,1
                     
                     
                        63,1
                     
                  2.2.   Type(s) of formulation of the meta SPC 4
            
            
                        Formulation(s)
                     
                     
                        Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation
                     
                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
            
            
                        Hazard statements
                     
                     
                        Highly flammable liquid and vapour.
                        Causes serious eye irritation.
                        May cause drowsiness or dizziness.
                        Repeated exposure may cause skin dryness or cracking.
                     
                  
                        Precautionary statements
                     
                     
                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Keep container tightly closed.
                        Ground and bond container and receiving equipment.
                        Use explosion-proof electrical/ventilating/lighting equipment.
                        Use non-sparking tools.
                        Take action to prevent static discharges.
                        Avoid breathing vapours.
                        Avoid breathing spray.
                        Use only outdoors or in a well-ventilated area.
                        Wear eye protection.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        Call a POISON CENTER or doctor if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        If eye irritation persists: Get medical attention.
                        In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
                        Store in a well-ventilated place. Keep cool.
                        Store locked up.
                        Dispose of contents/container to an approved waste disposal plant.
                     
                  4.   AUTHORISED USE(S) OF THE META SPC 4
            
            4.1.   Use description
            
            
               Table 11. Use # 1 – disinfection of surfaces – wiping
            
            
                        Product type
                     
                     
                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Scientific name: Bacteria including Mycobacterium tuberculosis
                        Common name: -
                        Development stage: -
                        Scientific name: Yeast
                        Common name: -
                        Development stage: -
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)
                     
                  
                        Application method(s)
                     
                     
                        Wiping
                        Product will be wiped directly on the surface.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Ready-to-use wipes – -
                        Disinfection when required according to SOP.
                     
                  
                        Category(ies) of users
                     
                     
                        Industrial
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Soft pack: 1-200 wipes
                        Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
                        Pouch: 10-200 wipes
                        Packaging material: LDPE/PET
                        Tub: 50-200 wipes
                        Packaging material: HDPE
                        closure material is either PP, PE3385
                     
                  4.1.1.   Use-specific instructions for use
            
            Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).
            4.1.2.   Use-specific risk mitigation measures
            
            See general directions for use.
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            -
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use.
            4.2.   Use description
            
            
               Table 12. Use # 2 – Disinfection of surfaces with food and feed contact – wiping
            
            
                        Product type
                     
                     
                        PT04 – Food and feed area (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Scientific name: Bacteria incl. Mycobacterium tuberculosis
                        Common name: -
                        Development stage: -
                        Scientific name: Yeast
                        Common name: -
                        Development stage: -
                        Scientific name: Viruses
                        Common name: -
                        Development stage: -
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
                     
                  
                        Application method(s)
                     
                     
                        Wiping
                        Product will be wiped directly on the surface.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Ready-to-use wipes
                        Disinfection when required according to SOP.
                     
                  
                        Category(ies) of users
                     
                     
                        Industrial
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Soft pack: 1-200 wipes
                        Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
                        Pouch: 10-200 wipes
                        Packaging material: LDPE/PET
                        Tub: 50-200 wipes
                        Packaging material: HDPE
                        closure material is either PP, PE3385
                     
                  4.2.1.   Use-specific instructions for use
            
            Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).
            4.2.2.   Use-specific risk mitigation measures
            
            See general directions for use.
            4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            -
            4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use.
            5.   GENERAL DIRECTIONS FOR USE (4)
               OF THE META SPC 4
            
            5.1.   Instructions for use
            
            Clean the surface carefully before use.
            Remove excess water from the surface before disinfection, if appropriate.
            Make sure to wet surfaces completely.
            Used wipes must be disposed in a closed container.
            5.2.   Risk mitigation measures
            
            The product must only be applied for disinfection of small surfaces.
            Ensure adequate ventilation to prevent the formation of explosive atmospheres.
            Avoid contact with eyes.
            Keep out of reach of children and pets.
            Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            First aid:
            
                         
                     
                     
                        In case of accident: Call a poison centre or a doctor.
                     
                  
                         
                     
                     
                        IF INHALED: Remove person to fresh air and keep comfortable for breathing.
                     
                  
                         
                     
                     
                        If on skin: Wash with water. If skin irritation occurs: Get medical advice.
                     
                  
                         
                     
                     
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
                     
                  
                         
                     
                     
                        IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
                     
                  5.4.   Instructions for safe disposal of the product and its packaging
            
            -
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage
            
            Shelf-life: 24 months
            Keep container tightly closed.
            Store in a well-ventilated place.
            Protect from sunlight.
            Store at room temperature in the original container.
            6.   OTHER INFORMATION
            
            The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
            
            7.1.   Trade name(s), authorisation number and specific composition of each individual product
            
            
                        Trade name(s)
                     
                     
                        Schülke® 9
                     
                     
                        Market area: EU
                     
                  
                        Authorisation number
                     
                     
                        EU-0023860-0004 1-4
                     
                  
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Propan-2-ol
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        67-63-0
                     
                     
                        200-661-7
                     
                     
                        63,1
                     
                  
               META SPC 5
            
            1.   META SPC 5 ADMINISTRATIVE INFORMATION
            
            1.1.   Meta SPC 5 identifier
            
            
                        Identifier
                     
                     
                        meta-SPC 5
                     
                  1.2.   Suffix to the authorisation number
            
            
                        Number
                     
                     
                        1-5
                     
                  1.3.   Product type(s)
            
            
                        Product type(s)
                     
                     
                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                        PT04 – Food and feed area (Disinfectants)
                     
                  2.   META SPC 5 COMPOSITION
            
            2.1.   Qualitative and quantitative information on the composition of the meta SPC 5
            
            
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Min
                     
                     
                        Max
                     
                  
                        Propan-2-ol
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        67-63-0
                     
                     
                        200-661-7
                     
                     
                        63,1
                     
                     
                        63,1
                     
                  2.2.   Type(s) of formulation of the meta SPC 5
            
            
                        Formulation(s)
                     
                     
                        Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation
                     
                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
            
            
                        Hazard statements
                     
                     
                        Highly flammable liquid and vapour.
                        Causes serious eye irritation.
                        May cause drowsiness or dizziness.
                        Repeated exposure may cause skin dryness or cracking.
                     
                  
                        Precautionary statements
                     
                     
                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Keep container tightly closed.
                        Ground and bond container and receiving equipment.
                        Use explosion-proof electrical/ventilating/lighting equipment.
                        Use non-sparking tools.
                        Take action to prevent static discharges.
                        Avoid breathing vapours.
                        Avoid breathing spray.
                        Use only outdoors or in a well-ventilated area.
                        Wear eye protection.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        Call a POISON CENTER or doctor if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        If eye irritation persists: Get medical attention.
                        In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
                        Store in a well-ventilated place. Keep cool.
                        Store locked up.
                        Dispose of contents/container to an approved waste disposal plant.
                     
                  4.   AUTHORISED USE(S) OF THE META SPC 5
            
            4.1.   Use description
            
            
               Table 13. Use # 1 – Disinfection of surfaces – wiping
            
            
                        Product type
                     
                     
                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Scientific name: Bacteria including Mycobacterium tuberculosis
                        Common name: -
                        Development stage: -
                        Scientific name: Yeast
                        Common name: -
                        Development stage: -
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)
                     
                  
                        Application method(s)
                     
                     
                        Wiping
                        Product will be wiped directly on the surface.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Ready-to-use wipes
                     
                  
                        Category(ies) of users
                     
                     
                        Industrial
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Soft pack: 1-200 wipes
                        Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
                        Pouch: 10-200 wipes
                        Packaging material: LDPE/PET
                        Tub: 50-200 wipes
                        Packaging material: HDPE
                        closure material is either PP, PE3385
                     
                  4.1.1.   Use-specific instructions for use
            
            Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).
            4.1.2.   Use-specific risk mitigation measures
            
            See general directions for use.
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            -
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use.
            4.2.   Use description
            
            
               Table 14. Use # 2 – Disinfection of surfaces with food and feed contact – wiping
            
            
                        Product type
                     
                     
                        PT04 – Food and feed area (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Scientific name: Bacteria including Mycobacterium tuberculosis
                        Common name: -
                        Development stage: -
                        Scientific name: Yeast
                        Common name: -
                        Development stage: -
                        Scientific name: Viruses
                        Common name: -
                        Development stage: -
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
                     
                  
                        Application method(s)
                     
                     
                        Wiping
                        Product will be wiped directly on the surface.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Ready-to-use wipes
                     
                  
                        Category(ies) of users
                     
                     
                        Industrial
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Soft pack: 1-200 wipes
                        Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
                        Pouch: 10-200 wipes
                        Packaging material: LDPE/PET
                        Tub: 50-200 wipes
                        Packaging material: HDPE
                        closure material is either PP, PE3385
                     
                  4.2.1.   Use-specific instructions for use
            
            Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).
            4.2.2.   Use-specific risk mitigation measures
            
            See general directions for use.
            4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            -
            4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use.
            5.   GENERAL DIRECTIONS FOR USE (5)
               OF THE META SPC 5
            
            5.1.   Instructions for use
            
            Clean the surface carefully before use.
            Remove excess water from the surface before disinfection, if appropriate.
            Make sure to wet surfaces completely.
            Used wipes must be disposed in a closed container.
            5.2.   Risk mitigation measures
            
            The product must only be applied for disinfection of small surfaces.
            Ensure adequate ventilation to prevent the formation of explosive atmospheres.
            Avoid contact with eyes.
            Keep out of reach of children and pets.
            Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            First aid:
            
                         
                     
                     
                        In case of accident: Call a poison centre or a doctor.
                     
                  
                         
                     
                     
                        IF INHALED: Remove person to fresh air and keep comfortable for breathing.
                     
                  
                         
                     
                     
                        If on skin: Wash with water. If skin irritation occurs: Get medical advice.
                     
                  
                         
                     
                     
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
                     
                  
                         
                     
                     
                        IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
                     
                  5.4.   Instructions for safe disposal of the product and its packaging
            
            -
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage
            
            Shelf-life: 24 months
            Keep container tightly closed.
            Store in a well-ventilated place.
            Protect from sunlight.
            Store at room temperature in the original container.
            6.   OTHER INFORMATION
            
            The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5
            
            7.1.   Trade name(s), authorisation number and specific composition of each individual product
            
            
                        Trade name(s)
                     
                     
                        Schülke® 10
                     
                     
                        Market area: EU
                     
                  
                        Authorisation number
                     
                     
                        EU-0023860-0005 1-5
                     
                  
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Propan-2-ol
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        67-63-0
                     
                     
                        200-661-7
                     
                     
                        63,1
                     
                  
               META SPC 6
            
            1.   META SPC 6 ADMINISTRATIVE INFORMATION
            
            1.1.   Meta SPC 6 identifier
            
            
                        Identifier
                     
                     
                        meta-SPC6 kodan wipes IPA
                     
                  1.2.   Suffix to the authorisation number
            
            
                        Number
                     
                     
                        1-6
                     
                  1.3.   Product type(s)
            
            
                        Product type(s)
                     
                     
                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                        PT04 – Food and feed area (Disinfectants)
                     
                  2.   META SPC 6 COMPOSITION
            
            2.1.   Qualitative and quantitative information on the composition of the meta SPC 6
            
            
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Min
                     
                     
                        Max
                     
                  
                        Propan-2-ol
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        67-63-0
                     
                     
                        200-661-7
                     
                     
                        63,1
                     
                     
                        63,1
                     
                  2.2.   Type(s) of formulation of the meta SPC 6
            
            
                        Formulation(s)
                     
                     
                        Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation
                     
                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6
            
            
                        Hazard statements
                     
                     
                        Highly flammable liquid and vapour.
                        Causes serious eye irritation.
                        May cause drowsiness or dizziness.
                        Repeated exposure may cause skin dryness or cracking.
                     
                  
                        Precautionary statements
                     
                     
                        If medical advice is needed, have product container or label at hand.
                        Keep out of reach of children.
                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Keep container tightly closed.
                        Ground and bond container and receiving equipment.
                        Use explosion-proof electrical/ventilating/lighting equipment.
                        Use non-sparking tools.
                        Take action to prevent static discharges.
                        Avoid breathing vapours.
                        Avoid breathing spray.
                        Use only outdoors or in a well-ventilated area.
                        IF INHALED: Remove person to fresh air and keep comfortable for breathing.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        Call a POISON CENTER or doctor if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        If eye irritation persists: Get medical attention.
                        In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
                        Store in a well-ventilated place. Keep cool.
                        Store locked up.
                        Dispose of contents/container to an approved waste disposal plant.
                     
                  4.   AUTHORISED USE(S) OF THE META SPC 6
            
            4.1.   Use description
            
            
               Table 15. Use # 1 – Disinfection of surfaces – wiping
            
            
                        Product type
                     
                     
                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Scientific name: Bacteria including Mycobacterium tuberculosis
                        Common name: -
                        Development stage: -
                        Scientific name: Yeast
                        Common name: -
                        Development stage: -
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)
                     
                  
                        Application method(s)
                     
                     
                        Wiping
                        Product will be wiped directly on the surface.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Ready-to-use wipes
                     
                  
                        Category(ies) of users
                     
                     
                        Industrial
                        Professional
                        General public (non-professional)
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Soft pack: 1-200 wipes
                        Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
                        Pouch: 10-200 wipes
                        Packaging material: LDPE/PET
                        Tub: 50-200 wipes
                        Packaging material: HDPE
                        closure material is either PP, PE3385
                     
                  4.1.1.   Use-specific instructions for use
            
            Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).
            4.1.2.   Use-specific risk mitigation measures
            
            See general directions for use.
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            -
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use.
            4.2.   Use description
            
            
               Table 16. Use # 2 – Disinfection of surfaces with food and feed contact – wiping
            
            
                        Product type
                     
                     
                        PT04 – Food and feed area (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Scientific name: Bacteria including Mycobacterium tuberculosis
                        Common name: -
                        Development stage: -
                        Scientific name: Yeast
                        Common name: -
                        Development stage: -
                        Scientific name: Viruses
                        Common name: -
                        Development stage: -
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
                     
                  
                        Application method(s)
                     
                     
                        Wiping
                        Product will be wiped directly on the surface.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Ready-to-use wipes
                     
                  
                        Category(ies) of users
                     
                     
                        Industrial
                        Professional
                        General public (non-professional)
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Soft pack: 1-200 wipes
                        Packaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPP
                        Pouch: 10-200 wipes
                        Packaging material: LDPE/PET
                        Tub: 50-200 wipes
                        Packaging material: HDPE
                        closure material is either PP, PE3385
                     
                  4.2.1.   Use-specific instructions for use
            
            Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).
            4.2.2.   Use-specific risk mitigation measures
            
            See general directions for use.
            4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            -
            4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use.
            5.   GENERAL DIRECTIONS FOR USE (6)
               OF THE META SPC 6
            
            5.1.   Instructions for use
            
            Clean the surface carefully before use.
            Remove excess water from the surface before disinfection, if appropriate.
            Make sure to wet surfaces completely.
            Used wipes must be disposed in a closed container.
            5.2.   Risk mitigation measures
            
            The product must only be applied for disinfection of small surfaces.
            Ensure adequate ventilation to prevent the formation of explosive atmospheres.
            Avoid contact with eyes.
            Keep out of the reach of children and pets.
            Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            First aid:
            
                         
                     
                     
                        In case of accident: Call a poison centre or a doctor.
                     
                  
                         
                     
                     
                        IF INHALED: Remove person to fresh air and keep comfortable for breathing.
                     
                  
                         
                     
                     
                        If on skin: Wash with water. If skin irritation occurs: Get medical advice.
                     
                  
                         
                     
                     
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
                     
                  
                         
                     
                     
                        IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
                     
                  5.4.   Instructions for safe disposal of the product and its packaging
            
            -
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage
            
            Shelf-life: 24 months
            Keep container tightly closed.
            Store in a well-ventilated place.
            Protect from sunlight.
            Store at room temperature in the original container.
            6.   OTHER INFORMATION
            
            The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6
            
            7.1.   Trade name(s), authorisation number and specific composition of each individual product
            
            
                        Trade name(s)
                     
                     
                        Schülke® 11
                     
                     
                        Market area: EU
                     
                  
                        Authorisation number
                     
                     
                        EU-0023860-0006 1-6
                     
                  
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Propan-2-ol
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        67-63-0
                     
                     
                        200-661-7
                     
                     
                        63,1
                     
                  
               META SPC 7
            
            1.   META SPC 7 ADMINISTRATIVE INFORMATION
            
            1.1.   Meta SPC 7 identifier
            
            
                        Identifier
                     
                     
                        meta-SPC7
                     
                  1.2.   Suffix to the authorisation number
            
            
                        Number
                     
                     
                        1-7
                     
                  1.3.   Product type(s)
            
            
                        Product type(s)
                     
                     
                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                        PT04 – Food and feed area (Disinfectants)
                     
                  2.   META SPC 7 COMPOSITION
            
            2.1.   Qualitative and quantitative information on the composition of the meta SPC 7
            
            
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Min
                     
                     
                        Max
                     
                  
                        Propan-2-ol
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        67-63-0
                     
                     
                        200-661-7
                     
                     
                        63,1
                     
                     
                        63,1
                     
                  2.2.   Type(s) of formulation of the meta SPC 7
            
            
                        Formulation(s)
                     
                     
                        Any other liquid (AL), ready-to-use
                     
                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7
            
            
                        Hazard statements
                     
                     
                        Highly flammable liquid and vapour.
                        Causes serious eye irritation.
                        May cause drowsiness or dizziness.
                        Repeated exposure may cause skin dryness or cracking.
                     
                  
                        Precautionary statements
                     
                     
                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Keep container tightly closed.
                        Ground and bond container and receiving equipment.
                        Use explosion-proof electrical/ventilating/lighting equipment.
                        Use non-sparking tools.
                        Take action to prevent static discharges.
                        Avoid breathing vapours.
                        Avoid breathing spray.
                        Use only outdoors or in a well-ventilated area.
                        Wear eye protection.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        Call a POISON CENTER or doctor if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        If eye irritation persists: Get medical attention.
                        In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
                        Store in a well-ventilated place. Keep cool.
                        Store locked up.
                        Dispose of contents/container to an approved waste disposal plant.
                     
                  4.   AUTHORISED USE(S) OF THE META SPC 7
            
            4.1.   Use description
            
            
               Table 17. Use # 1 – Disinfection of surfaces – spraying
            
            
                        Product type
                     
                     
                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Scientific name: Bacteria
                        Common name: -
                        Development stage: -
                        Scientific name: Yeast
                        Common name: -
                        Development stage: -
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)
                     
                  
                        Application method(s)
                     
                     
                        Spraying
                        Product will be sprayed directly on the surface.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Ready-to-use. Do not apply more than 25 ml/m2.
                     
                  
                        Category(ies) of users
                     
                     
                        Industrial
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Bottle: 125-1000 ml
                        packaging material: HDPE
                        Clack cap material: PP;
                        Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel);
                        Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)
                     
                  4.1.1.   Use-specific instructions for use
            
            Spray ready-to-use product onto the surfaces and allow to take effect for at least 1 minute at room temperature (20 ± 2 °C).
            4.1.2.   Use-specific risk mitigation measures
            
            The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures:
            Wear eye protection during handling of the product.
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            -
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use.
            4.2.   Use description
            
            
               Table 18. Use # 2 – disinfection of surfaces – wiping
            
            
                        Product type
                     
                     
                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Scientific name: Bacteria
                        Common name: -
                        Development stage: -
                        Scientific name: Yeast
                        Common name: -
                        Development stage: -
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)
                     
                  
                        Application method(s)
                     
                     
                        Wiping
                        Product is applied on wipes by pouring, spraying or soaking and the surface is thoroughly wiped with the soaked wipe afterwards (wet-wiping).
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Ready-to-use. Do not apply more than 25 ml/m2.
                     
                  
                        Category(ies) of users
                     
                     
                        Industrial
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Bottle: 125-1000 ml
                        packaging material: HDPE
                        Clack cap material: PP
                        Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel);
                        Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)
                        Canister: 5-30 L
                        packaging material: HDPE
                        closure material: HDPE
                     
                  4.2.1.   Use-specific instructions for use
            
            Apply the ready-to-use product on wipes by pouring, spraying or soaking and wipe the surface thoroughly with the wet wipe (wet-wiping). Allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).
            4.2.2.   Use-specific risk mitigation measures
            
            The following personal risk mitigation measure can be applied for refilling procedure unless it can be replaced by technical and/or organisational measures:
            Wear eye protection during handling of the product.
            4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            -
            4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use.
            4.3.   Use description
            
            
               Table 19. Use # 3 – Disinfection of surfaces with food and feed contact – spraying
            
            
                        Product type
                     
                     
                        PT04 – Food and feed area (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Scientific name: Bacteria
                        Common name: -
                        Development stage: -
                        Scientific name: Yeast
                        Common name: -
                        Development stage: -
                        Scientific name: Viruses
                        Common name: -
                        Development stage: -
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
                     
                  
                        Application method(s)
                     
                     
                        Spraying
                        Product will be sprayed directly on the surface.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Ready-to-use. Do not apply more than 25 ml/m2.
                        -
                     
                  
                        Category(ies) of users
                     
                     
                        Industrial
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Bottle: 125-1000 ml
                        packaging material: HDPE
                        Clack cap material: PP
                        Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel)
                        Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)
                     
                  4.3.1.   Use-specific instructions for use
            
            Spray ready-to-use product onto the surface and allow to take effect at room temperature (20 ± 2 °C) for at least 1 minute (bactericidal and yeasticidal activity) or 2 minutes (virucidal activity).
            4.3.2.   Use-specific risk mitigation measures
            
            The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures:
            Wear eye protection during handling of the product.
            4.3.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            -
            4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use.
            4.4.   Use description
            
            
               Table 20. Use # 4 – Disinfection of surfaces with food and feed contact – wiping
            
            
                        Product type
                     
                     
                        PT04 – Food and feed area (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Scientific name: Bacteria
                        Common name: -
                        Development stage: -
                        Scientific name: Yeast
                        Common name: -
                        Development stage: -
                        Scientific name: Viruses
                        Common name: -
                        Development stage: -
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
                     
                  
                        Application method(s)
                     
                     
                        Wiping
                        Product is applied on wipes by pouring, spraying or soaking and the surface is thoroughly wiped with the soaked wipe afterwards (wet-wiping).
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Ready-to-use. Do not apply more than 25 ml/m2.
                     
                  
                        Category(ies) of users
                     
                     
                        Industrial
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Bottle: 125-1000 ml
                        packaging material: HDPE
                        Clack cap material: PP
                        Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel);
                        Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil)
                        Canister: 5-30 L
                        packaging material: HDPE
                        closure material: HDPE
                     
                  4.4.1.   Use-specific instructions for use
            
            Apply the ready-to-use product on wipes by pouring, spraying or soaking and wipe the surface thoroughly with the wet wipe (wet-wiping). Allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).
            4.4.2.   Use-specific risk mitigation measures
            
            The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures:
            Wear eye protection during handling of the product.
            4.4.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            -
            4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use.
            5.   GENERAL DIRECTIONS FOR USE (7)
               OF THE META SPC 7
            
            5.1.   Instructions for use
            
            Clean the surface carefully before use.
            Remove excess water from the surface before disinfection, if appropriate.
            Do not apply more than 25 ml/m2.
            Make sure to wet surfaces completely.
            Used wipes must be disposed in a closed container.
            5.2.   Risk mitigation measures
            
            The product must only be applied for disinfection of small surfaces.
            Ensure adequate ventilation to prevent the formation of explosive atmospheres.
            Avoid contact with eyes.
            Apply a funnel for refilling.
            Keep out of reach of children and pets.
            Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            First aid:
            
                         
                     
                     
                        In case of accident: Call a poison centre or a doctor.
                     
                  
                         
                     
                     
                        IF INHALED: Remove person to fresh air and keep comfortable for breathing.
                     
                  
                         
                     
                     
                        If on skin: Wash with water. If skin irritation occurs: Get medical advice.
                     
                  
                         
                     
                     
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
                     
                  
                         
                     
                     
                        IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
                     
                  5.4.   Instructions for safe disposal of the product and its packaging
            
            -
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage
            
            Shelf-life: 36 months
            Keep container tightly closed.
            Store in a well-ventilated place.
            Protect from sunlight.
            Store at room temperature in the original container.
            6.   OTHER INFORMATION
            
            The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7
            
            7.1.   Trade name(s), authorisation number and specific composition of each individual product
            
            
                        Trade name(s)
                     
                     
                        Superficid®
                        Desocid rapid
                        Neoseptin rapid
                        Novosept rapid
                        Novoseptin rapid
                        Lyorthol rapid
                        Cosmo rapid
                        Fordesin rapid
                        Saltero rapid
                        Prop70 rapid
                        Aldovet rapid
                        Vetfarm rapid
                        MDI rapid
                        Antiseptica rapid
                        Sterisol Surface
                        MENNO® I-QUICK plus
                     
                     
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                     
                  
                        Authorisation number
                     
                     
                        EU-0023860-0007 1-7
                     
                  
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Propan-2-ol
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        67-63-0
                     
                     
                        200-661-7
                     
                     
                        63,1
                     
                  7.2.   Trade name(s), authorisation number and specific composition of each individual product
            
            
                        Trade name(s)
                     
                     
                        Superficid® pure
                        Desocid rapid pure
                        Neoseptin rapid pure
                        Novosept rapid pure
                        Novoseptin rapid pure
                        Lyorthol rapid pure
                        Cosmo rapid pure
                        Fordesin rapid pure
                        Saltero rapid pure
                        Prop70 rapid pure
                        Aldovet rapid pure
                        Vetfarm rapid pure
                        MDI rapid pure
                        Antiseptica rapid pure
                        Sterisol Surface pure
                        BTS 6000
                        MENNO® I-QUICK
                        EWA® DES ready
                        Kiehl-Rapinol
                        Des A
                     
                     
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                     
                  
                        Authorisation number
                     
                     
                        EU-0023860-0008 1-7
                     
                  
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Propan-2-ol
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        67-63-0
                     
                     
                        200-661-7
                     
                     
                        63,1
                     
                  
               META SPC 8
            
            1.   META SPC 8 ADMINISTRATIVE INFORMATION
            
            1.1.   Meta SPC 8 identifier
            
            
                        Identifier
                     
                     
                        meta-SPC8
                     
                  1.2.   Suffix to the authorisation number
            
            
                        Number
                     
                     
                        1-8
                     
                  1.3.   Product type(s)
            
            
                        Product type(s)
                     
                     
                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                        PT04 – Food and feed area (Disinfectants)
                     
                  2.   META SPC 8 COMPOSITION
            
            2.1.   Qualitative and quantitative information on the composition of the meta SPC 8
            
            
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Min
                     
                     
                        Max
                     
                  
                        Propan-2-ol
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        67-63-0
                     
                     
                        200-661-7
                     
                     
                        63,1
                     
                     
                        63,1
                     
                  2.2.   Type(s) of formulation of the meta SPC 8
            
            
                        Formulation(s)
                     
                     
                        Any other liquid (AL), ready-to-use wipes impregnated with disinfectant formulation
                     
                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8
            
            
                        Hazard statements
                     
                     
                        Highly flammable liquid and vapour.
                        Causes serious eye irritation.
                        May cause drowsiness or dizziness.
                        Repeated exposure may cause skin dryness or cracking.
                     
                  
                        Precautionary statements
                     
                     
                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Keep container tightly closed.
                        Ground and bond container and receiving equipment.
                        Use explosion-proof electrical/ventilating/lighting equipment.
                        Use non-sparking tools.
                        Take action to prevent static discharges.
                        Avoid breathing vapours.
                        Avoid breathing spray.
                        Use only outdoors or in a well-ventilated area.
                        Wear eye protection.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        Call a POISON CENTER or doctor if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        If eye irritation persists: Get medical attention.
                        In case of fire: Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.
                        Store in a well-ventilated place. Keep cool.
                        Store locked up.
                        Dispose of contents/container to an approved waste disposal plant.
                     
                  4.   AUTHORISED USE(S) OF THE META SPC 8
            
            4.1.   Use description
            
            
               Table 21. Use # 1 – Disinfection of surfaces – wiping
            
            
                        Product type
                     
                     
                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Scientific name: Bacteria
                        Common name: -
                        Development stage: -
                        Scientific name: Yeast
                        Common name: -
                        Development stage: -
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B)
                     
                  
                        Application method(s)
                     
                     
                        Wiping
                        Product will be wiped directly on the surface.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Ready-to-use wipes
                     
                  
                        Category(ies) of users
                     
                     
                        Industrial
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Can: 100-150 wipes
                        Packaging: HDPE
                        Closure material: HDPE
                        Pack: 100-150 wipes
                        Packaging: PET/PE
                     
                  4.1.1.   Use-specific instructions for use
            
            Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).
            4.1.2.   Use-specific risk mitigation measures
            
            See general directions for use.
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            -
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use.
            4.2.   Use description
            
            
               Table 22. Use # 2 – Disinfection of surfaces with food and feed contact – wiping
            
            
                        Product type
                     
                     
                        PT04 – Food and feed area (Disinfectants)
                     
                  
                        Where relevant, an exact description of the authorised use
                     
                     
                        -
                     
                  
                        Target organism(s) (including development stage)
                     
                     
                        Scientific name: Bacteria
                        Common name: -
                        Development stage: -
                        Scientific name: Yeast
                        Common name: -
                        Development stage: -
                        Scientific name: Viruses
                        Common name: -
                        Development stage: -
                     
                  
                        Field(s) of use
                     
                     
                        Indoor
                        Disinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
                     
                  
                        Application method(s)
                     
                     
                        Wiping
                        Product will be wiped directly on the surface.
                     
                  
                        Application rate(s) and frequency
                     
                     
                        Ready-to-use wipes
                     
                  
                        Category(ies) of users
                     
                     
                        Industrial
                        Professional
                     
                  
                        Pack sizes and packaging material
                     
                     
                        Can: 100-150 wipes
                        Packaging: HDPE
                        Closure material: HDPE
                        Pack: 100-150 wipes
                        Packaging: PET/PE
                     
                  4.2.1.   Use-specific instructions for use
            
            Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C).
            4.2.2.   Use-specific risk mitigation measures
            
            See general directions for use.
            4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            See general directions for use.
            4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
            
            -
            4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
            
            See general directions for use.
            5.   GENERAL DIRECTIONS FOR USE (8)
               OF THE META SPC 8
            
            5.1.   Instructions for use
            
            Clean the surface carefully before use.
            Remove excess water from the surface before disinfection, if appropriate.
            Make sure to wet surfaces completely.
            Used wipes must be disposed in a closed container.
            5.2.   Risk mitigation measures
            
            The product must only be applied for disinfection of small surfaces.
            Ensure adequate ventilation to prevent the formation of explosive atmospheres.
            Avoid contact with eyes.
            Keep out of reach of children and pets.
            Keep children and pets away from rooms where disinfection is taking place. Provide adequate ventilation before children and pets enter treated rooms. This does not apply to hospital patient rooms.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
            
            First aid:
            
                         
                     
                     
                        In case of accident: Call a poison centre or a doctor.
                     
                  
                         
                     
                     
                        IF INHALED: Remove person to fresh air and keep comfortable for breathing.
                     
                  
                         
                     
                     
                        If on skin: Wash with water. If skin irritation occurs: Get medical advice.
                     
                  
                         
                     
                     
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
                     
                  
                         
                     
                     
                        IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
                     
                  5.4.   Instructions for safe disposal of the product and its packaging
            
            -
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage
            
            Shelf-life: 24 months
            Keep container tightly closed.
            Store in a well-ventilated place.
            Protect from sunlight.
            Store at room temperature in the original container.
            6.   OTHER INFORMATION
            
            The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8
            
            7.1.   Trade name(s), authorisation number and specific composition of each individual product
            
            
                        Trade name(s)
                     
                     
                        Descorapid® Tücher
                        Desocid Tücher
                        Neoseptin Tücher
                        Novosept Tücher
                        Novoseptin Tücher
                        Lyorthol Tücher
                        Cosmo Tücher
                        Fordesin Tücher
                        Saltero Tücher
                        Prop70 Tücher
                        Manosafe Tücher
                        Dermoguard Tücher
                        Dermosafe Tücher
                        Aldovet Tücher
                        Vetfarm Tücher
                        MDI Tücher
                        Antiseptica Tücher
                        Antiseptica wipes
                        MENNO®WIP
                        Descorapid® wipes
                        Desocid wipes
                        Neoseptin wipes
                        Novosept wipes
                        Novoseptin wipes
                        Lyorthol wipes
                        Cosmo wipes
                        Fordesin wipes
                        Saltero wipes
                        Prop70 wipes
                        Manosafe wipes
                        Dermoguard wipes
                        Dermosafe wipes
                        Aldovet wipes
                        Vetfarm wipes
                        MDI wipes
                     
                     
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                     
                  
                        Authorisation number
                     
                     
                        EU-0023860-0009 1-8
                     
                  
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Propan-2-ol
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        67-63-0
                     
                     
                        200-661-7
                     
                     
                        63,1
                     
                  7.2.   Trade name(s), authorisation number and specific composition of each individual product
            
            
                        Trade name(s)
                     
                     
                        Superficid® pure wipes
                        Desocid rapid pure wipes
                        Neoseptin rapid pure wipes
                        Novosept rapid pure wipes
                        Novoseptin rapid pure wipes
                        Lyorthol rapid pure wipes
                        Cosmo rapid pure wipes
                        Fordesin rapid pure wipes
                        Saltero rapid pure wipes
                        Prop70 rapid pure wipes
                        Aldovet rapid pure wipes
                        Vetfarm rapid pure wipes
                        MDI rapid pure wipes
                        Antiseptica rapid pure wipes
                     
                     
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                        Market area: EU
                     
                  
                        Authorisation number
                     
                     
                        EU-0023860-0010 1-8
                     
                  
                        Common name
                     
                     
                        IUPAC name
                     
                     
                        Function
                     
                     
                        CAS number
                     
                     
                        EC number
                     
                     
                        Content (%)
                     
                  
                        Propan-2-ol
                     
                     
                         
                     
                     
                        Active Substance
                     
                     
                        67-63-0
                     
                     
                        200-661-7
                     
                     
                        63,1
                     
                  
               (1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.
            
               (2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.
            
               (3)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.
            
               (4)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.
            
               (5)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 5.
            
               (6)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 6.
            
               (7)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 7.
            
               (8)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 8.