COMMISSION IMPLEMENTING REGULATION (EU) 2023/2087

29.9.2023 | EN | Official Journal of the European Union | L 241/78 ---|---|---|--- * * * COMMISSION IMPLEMENTING REGULATION (EU) 2023/2087 of 28 September 2023 granting a Union authorisation for the biocidal product family ‘Lysoform IPA Surface’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5), first subparagraph, thereof, Whereas: (1) | On 25 November 2022, Lysoform Dr Hans Rosemann 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 a same biocidal product family, as referred to in Article 1 of that Regulation, named ‘Lysoform IPA Surface’, for product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-DP082158-26 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference biocidal product family ‘Lyso IPA Surface Disinfection’, recorded in the Register under case number BC-GX025200-35. ---|--- (2) | The same biocidal product family ‘Lysoform IPA Surface’ contains propan-2-ol as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 4. ---|--- (3) | On 31 March 2023, the Agency submitted to the Commission its opinion (3) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Lysoform IPA Surface’ in accordance with Article 6 of Implementing Regulation (EU) No 414/2013. ---|--- (4) | The opinion concludes 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), and that based on the assessment of the related reference biocidal product family ‘Lyso IPA Surface Disinfection’ 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 31 March 2023, 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 ‘Lysoform IPA Surface’. ---|--- (7) | The expiry date of this authorisation is aligned to the expiry date of the reference biocidal product family ‘Lyso IPA Surface Disinfection’. ---|--- (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-0030790-0000 is hereby granted to Lysoform Dr Hans Rosemann GmbH for the making available on the market and use of the same biocidal product family ‘Lysoform IPA Surface’ in accordance with the summary of the biocidal product characteristics set out in the Annex. The Union authorisation is valid from 19 October 2023 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, 28 September 2023. 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 for ‘Lysoform IPA Surface’, 31 March 2023, https://echa.europa.eu/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). * * * ANNEX Summary of product characteristics for a biocidal product family Lysoform IPA Surface 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-0030790-0000 R4BP asset number: EU-0030790-0000 PART I FIRST INFORMATION LEVEL 1\. ADMINISTRATIVE INFORMATION 1.1. Family name Name | Lysoform IPA Surface ---|--- 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 | Lysoform Dr Hans Rosemann GmbH ---|---|--- Address | Kaiser-Wilhelm-Str. 133, 12247 Berlin Germany Authorisation number | EU-0030790-0000 R4BP asset number | EU-0030790-0000 Date of the authorisation | 19 October 2023 Expiry date of the authorisation | 30 November 2030 1.4. Manufacturer(s) of the biocidal products 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 | 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 | 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 | Sterisol AB ---|--- Address of manufacturer | Kronoängsgatan 3, 592 23 Vadstena Sweden Location of manufacturing sites | Kronoängsgatan 3, 592 23 Vadstena Sweden Name of manufacturer | WHR GmbH ---|--- Address of manufacturer | Am Galgenturm 2, 97638 Mellrichstadt Germany Location of manufacturing sites | Am Galgenturm 2, 97638 Mellrichstadt Germany Name of manufacturer | Hygan GmbH | Srl ---|--- Address of manufacturer | Meucci-Str. 5, 39055 Leifers | Laives (BZ) Italy Location of manufacturing sites | Meucci-Str. 5, 39055 Leifers | Laives (BZ) Italy Name of manufacturer | Laboratoire Sarbec SA ---|--- Address of manufacturer | 10 rue du Vertuquet, 59960 Neuville-en-Ferrain France Location of manufacturing sites | 10 rue du Vertuquet, 59960 Neuville-en-Ferrain France Name of manufacturer | Dr Schumacher GmbH ---|--- Address of manufacturer | Am Roggenfeld 3, 34323 Malsfeld Germany Location of manufacturing sites | Am Roggenfeld 3, 34323 Malsfeld Germany Jeleniogórska 12, 59-800 Lubań Poland 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 | Superficid® ---|--- 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 to/container to an approved waste disposal plant. 4\. AUTHORISED USE(S) OF THE META SPC 1 4.1. Use description Table 1 Use # 1 disinfection of surfaces – spraying Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Field(s) of use | Indoor Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B) Application method(s) | Method: Spraying Detailed description: Product will be sprayed directly on the surface. Application rate(s) and frequency | Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application: - Category(ies) of users | Industrial Professional Pack sizes and packaging material | Bottle: 125-1 000 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 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) | Method: Wiping Detailed description: Product is applied on wipes by pouring, spraying or soaking and the surface is thoroughly wiped with the soaked wipe afterwards (wet-wiping). Application rate(s) and frequency | Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application: - Category(ies) of users | Industrial Professional Pack sizes and packaging material | Bottle: 125-1 000 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 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) | Method: Spraying Detailed description: Product will be sprayed directly on the surface. Application rate(s) and frequency | Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application: - Category(ies) of users | Industrial Professional Pack sizes and packaging material | Bottle: 125-1 000 ml packaging material: HDPE Clack cap material: PP Fine mist-sprayer: complex system (PE-LD, PP, PBT, POM, EVA, stainless steel) Spray head: complex system (PP, PE, POM, Synthetic oil, Silicon oil) 4.3.1. Use-specific instructions for use Spray ready-to-use product onto the surface and allow to take effect at room temperature (20 ± 2 °C) for at least 1 (bactericidal and yeasticidal activity) or 2 minutes (virucidal activity). 4.3.2. Use-specific risk mitigation measures The following personal risk mitigation measure can be applied for disinfection of food processing machinery and for refilling procedure unless it can be replaced by technical and/or organisational measures: Wear eye protection during handling of the product. 4.3.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use. 4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging 4.3.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 4.4. Use description Table 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) | Method: Wiping Detailed description: Product is applied on wipes by pouring, spraying or soaking and the surface is thoroughly wiped with the soaked wipe afterwards (wet-wiping). Application rate(s) and frequency | Application Rate: Ready-to-use. Do not apply more than 25 ml/m2. Dilution (%): - Number and timing of application: - Category(ies) of users | Industrial Professional Pack sizes and packaging material | Bottle: 125-1 000 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 (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) | Superficid® | Market area: EU ---|---|--- | Desocid rapid | Market area: EU Neoseptin rapid | Market area: EU Novosept rapid | Market area: EU Novoseptin rapid | Market area: EU Lyorthol rapid | Market area: EU Cosmo rapid | Market area: EU Fordesin rapid | Market area: EU Saltero rapid | Market area: EU Prop70 rapid | Market area: EU Aldovet rapid | Market area: EU Vetfarm rapid | Market area: EU MDI rapid | Market area: EU Antiseptica rapid | Market area: EU Sterisol Surface | Market area: EU MENNO® I-QUICK plus | Market area: EU Authorisation number | EU-0030790-0001 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 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | Superficid® pure | Market area: EU ---|---|--- | Desocid rapid pure | Market area: EU Neoseptin rapid pure | Market area: EU Novosept rapid pure | Market area: EU Novoseptin rapid pure | Market area: EU Lyorthol rapid pure | Market area: EU Cosmo rapid pure | Market area: EU Fordesin rapid pure | Market area: EU Saltero rapid pure | Market area: EU Prop70 rapid pure | Market area: EU Aldovet rapid pure | Market area: EU Vetfarm rapid pure | Market area: EU MDI rapid pure | Market area: EU Antiseptica rapid pure | Market area: EU Sterisol Surface pure | Market area: EU BTS 6000 | Market area: EU MENNO® I-QUICK | Market area: EU EWA® DES ready | Market area: EU Kiehl-Rapinol | Market area: EU Des A | Market area: EU Authorisation number | EU-0030790-0002 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 | Descorapid® ---|--- 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 to/container to an approved waste disposal plant. 4\. AUTHORISED USE(S) OF THE META SPC 2 4.1. Use description Table 5 Use # 1 – disinfection of surfaces – wiping Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) ---|--- Where relevant, an exact description of the authorised use | - Target organism(s) (including development stage) | Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Field(s) of use | Indoor Disinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas as well as surfaces in cleanrooms (class A/B) Application method(s) | Method: Wiping Detailed description: Product will be wiped directly on the surface. Application rate(s) and frequency | Application Rate: Ready-to-use wipes Dilution (%): - Number and timing of application: - Category(ies) of users | Industrial Professional Pack sizes and packaging material | Can: 100-150 wipes Packaging: HDPE Closure material: HDPE Pack: 100-150 wipes Packaging: PET/PE 4.1.1. Use-specific instructions for use Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C). 4.1.2. Use-specific risk mitigation measures See general directions for use. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 4.2. Use description Table 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) | Method: Wiping Detailed description: Product will be wiped directly on the surface. Application rate(s) and frequency | Application Rate: Ready-to-use wipes Dilution (%): - Number and timing of application: - Category(ies) of users | Industrial Professional Pack sizes and packaging material | Can: 100-150 wipes Packaging: HDPE Closure material: HDPE Pack: 100-150 wipes Packaging: PET/PE 4.2.1. Use-specific instructions for use Thoroughly wipe the surface with the wipe and allow to take effect for at least 5 minutes at room temperature (20 ± 2 °C). 4.2.2. Use-specific risk mitigation measures See general directions for use. 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 5\. GENERAL DIRECTIONS FOR USE (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) | Descorapid® Tücher | Market area: EU ---|---|--- | Desocid Tücher | Market area: EU Neoseptin Tücher | Market area: EU Novosept Tücher | Market area: EU Novoseptin Tücher | Market area: EU Lyorthol Tücher | Market area: EU Cosmo Tücher | Market area: EU Fordesin Tücher | Market area: EU Saltero Tücher | Market area: EU Prop70 Tücher | Market area: EU Manosafe Tücher | Market area: EU Dermoguard Tücher | Market area: EU Dermosafe Tücher | Market area: EU Aldovet Tücher | Market area: EU Vetfarm Tücher | Market area: EU MDI Tücher | Market area: EU Antiseptica Tücher | Market area: EU Antiseptica wipes | Market area: EU MENNO®WIP | Market area: EU Descorapid® wipes | Market area: EU Desocid wipes | Market area: EU Neoseptin wipes | Market area: EU Novosept wipes | Market area: EU Novoseptin wipes | Market area: EU Lyorthol wipes | Market area: EU Cosmo wipes | Market area: EU Fordesin wipes | Market area: EU Saltero wipes | Market area: EU Prop70 wipes | Market area: EU Manosafe wipes | Market area: EU Dermoguard wipes | Market area: EU Dermosafe wipes | Market area: EU Aldovet wipes | Market area: EU Vetfarm wipes | Market area: EU MDI wipes | Market area: EU Antiseptica wipes | Market area: EU Authorisation number | EU-0030790-0003 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 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) | Superficid® pure wipes | Market area: EU ---|---|--- | Desocid rapid pure wipes | Market area: EU Neoseptin rapid pure wipes | Market area: EU Novosept rapid pure wipes | Market area: EU Novoseptin rapid pure wipes | Market area: EU Lyorthol rapid pure wipes | Market area: EU Cosmo rapid pure wipes | Market area: EU Fordesin rapid pure wipes | Market area: EU Saltero rapid pure wipes | Market area: EU Prop70 rapid pure wipes | Market area: EU Aldovet rapid pure wipes | Market area: EU Vetfarm rapid pure wipes | Market area: EU MDI rapid pure wipes | Market area: EU Antiseptica rapid pure wipes | Market area: EU Authorisation number | EU-0030790-0004 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 * * * (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. * * *