COMMISSION IMPLEMENTING REGULATION (EU) 2021/978

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. * * *