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)
Commission Implementing Regulation (EU) 2021/978of 10 June 2021granting 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 productsOJ L 167, 27.6.2012, p. 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 414/2013Commission 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). 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 opinionECHA 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 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 354/2013Commission 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)., 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) 2017/2100Commission 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). 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 1A 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 2This 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 CommissionThe PresidentUrsula von der LeyenANNEXSummary of product characteristics for a biocidal product familyLyso IPA Surface DisinfectionProduct 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-0023860-0000R4BP asset number: EU-0023860-0000PART IFIRST INFORMATION LEVEL1.ADMINISTRATIVE INFORMATION1.1.Family name
NameLyso 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 holderNameSchülke & Mayr GmbH
AddressRobert-Koch-Str. 2, 22851, Norderstedt, Germany
Authorisation numberEU-0023860-0000
R4BP asset numberEU-0023860-0000
Date of the authorisation8 July 2021
Expiry date of the authorisation30 November 2030
1.4.Manufacturer(s) of the biocidal products
Name of manufacturerSchülke & Mayr GmbH
Address of manufacturerRobert-Koch-Str. 2, 22851 Norderstedt Germany
Location of manufacturing sitesRobert-Koch-Str. 2, 22851 Norderstedt Germany
Name of manufacturerBOCHEMIE a.s.
Address of manufacturerLidická 326, 735 95 Bohumín Czech Republic
Location of manufacturing sitesLidická 326, 735 95 Bohumín Czech Republic
Name of manufacturerImeco
Address of manufacturerBoschstr. 5, 63768 Hösbach Germany
Location of manufacturing sitesBoschstr. 5, 63768 Hösbach GermanyNeue Straße 2-4, 09471 Köningswalde Germany
Name of manufacturerTristel Solutions Limited
Address of manufacturerLynx Business Park, Fordham Road, Snailwell, CB8 7NY Cambridgeshire United Kingdom
Location of manufacturing sitesLynx Business Park, Fordham Road, Snailwell, CB8 7NY Cambridgeshire United Kingdom
Name of manufacturerTechtex
Address of manufacturerUnits 7&8 Rhodes Bus. Park Silburn Way, M24 4NE Middleton United Kingdom
Location of manufacturing sitesUnits 7&8 Rhodes Bus. Park Silburn Way, M24 4NE Middleton United Kingdom
Name of manufacturerA.F.P. GmbH
Address of manufacturerOtto Brenner Straße 16, 21337 Lüneburg Germany
Location of manufacturing sitesOtto Brenner Straße 16, 21337 Lüneburg Germany
Name of manufacturerInnovate GmbH
Address of manufacturerAm Hohen Stein 11, 06618 Naumbourg (Saale) Germany
Location of manufacturing sitesAm Hohen Stein 11, 06618 Naumbourg (Saale) Germany
Name of manufacturerLysoform Dr. Hans Rosemann GmbH
Address of manufacturerKaiser-Wilhelm-Straße 133, 12247 Berlin Germany
Location of manufacturing sitesKaiser-Wilhelm-Straße 133, 12247 Berlin Germany
Name of manufacturerSterisol AB
Address of manufacturerKronoängsgatan 3, 592 23 Vadstena Sweden
Location of manufacturing sitesKronoängsgatan 3, 592 23 Vadstena Sweden
Name of manufacturerRudolf Dankwardt GmbH
Address of manufacturerGutenbergring 50-52, 22848 Norderstedt Germany
Location of manufacturing sitesGutenbergring 50-52, 22848 Norderstedt GermanyLagerstr. 15, 19249 Jessenitz - Werk/Lübtheen Germany
1.5.Manufacturer(s) of the active substance(s)
Active substancePropan-2-ol
Name of manufacturerIneos Solvents Germany GmbH (formerly Sasol)
Address of manufacturerRömerstraße 733, 47443 Moers Germany
Location of manufacturing sitesRömerstraße 733, 47443 Moers GermanyShamrockstr. 88, 44643 Herne Germany
Active substancePropan-2-ol
Name of manufacturerShell Chemicals Europe B.V.
Address of manufacturerPostbus 2334, 3000 CH Rotterdam Netherlands
Location of manufacturing sitesShell Nederland Raffinaderij B.V., Vondelingenweg 601, 3196 KK Rotterdam-Pernis Netherlands
2.PRODUCT FAMILY COMPOSITION AND FORMULATION2.1.Qualitative and quantitative information on the composition of the family
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Propan-2-olActive Substance67-63-0200-661-763,163,1
2.2.Type(s) of formulation
Formulation(s)Any other liquid (AL), ready-to-useAny other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation
PART IISECOND INFORMATION LEVEL – META SPC(S)META SPC 11.META SPC 1 ADMINISTRATIVE INFORMATION1.1.Meta SPC 1 identifier
Identifiermeta-SPC1
1.2.Suffix to the authorisation number
Number1-1
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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 1
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Propan-2-olActive Substance67-63-0200-661-763,163,1
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 statementsHighly flammable liquid and vapour.Causes serious eye irritation.May cause drowsiness or dizziness.Repeated exposure may cause skin dryness or cracking.
Precautionary statementsKeep 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 14.1.Use description
Table 1. Use # 1 – Disinfection of surfaces – spraying
Product typePT02 – 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: BacteriaCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -
Field(s) of useIndoorDisinfection 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)SprayingProduct will be sprayed directly on the surface
Application rate(s) and frequencyReady-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 usersIndustrialProfessional
Pack sizes and packaging materialBottle: 250-1000 mlpackaging 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 PPcanister: 5-10 Lpackaging material: HDPE.closure material is either: HDPE/LDPERevolver BAG: 1 Lpackaging material: EVAclosure material: PP/Silicone/EVA
4.1.1.Use-specific instructions for useSpray 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 measuresThe 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 environmentSee general directions for use.4.1.4.Where specific to the use, the instructions for safe disposal of the product and its packaging4.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use.
4.2.Use description
Table 2. Use # 2 – Disinfection of surfaces – wiping
Product typePT02 – 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: BacteriaCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -
Field(s) of useIndoorDisinfection 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)WipingProduct 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 frequencyReady-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 usersIndustrialProfessional
Pack sizes and packaging materialBottle: 250-1000 mlpackaging material: HDPE, surlyn/PPclosure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP.canister: 5-10 Lpackaging material: HDPE.closure material is either: HDPE/LDPERevolver BAG: 1 Lpackaging material: EVAclosure material: PP/Silicone/EVA.
4.2.1.Use-specific instructions for useSpray 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 measuresThe 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 environmentSee general directions for use.4.2.4.Where specific to the use, the instructions for safe disposal of the product and its packaging4.2.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use.
4.3.Use description
Table 3. Use # 3 – Disinfection of surfaces with food and feed contact – spraying
Product typePT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use-
Target organism(s) (including development stage)Scientific name: BacteriaCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: VirusesCommon name: -Development stage: -
Field(s) of useIndoorDisinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
Application method(s)SprayingProduct will be sprayed directly on the surface.
Application rate(s) and frequencyReady-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 usersIndustrialProfessional
Pack sizes and packaging materialBottle: 250-1000 mlpackaging material: HDPE, surlyn/PPclosure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP.canister: 5-10 Lpackaging material: HDPE.closure material is either: HDPE/LDPERevolver BAG: 1 Lpackaging material: EVAclosure material: PP/Silicone/EVA.
4.3.1.Use-specific instructions for useSpray 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 measuresThe 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 environmentSee 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 storageSee general directions for use.
4.4.Use description
Table 4. Use # 4 – Disinfection of surfaces with food and feed contact – wiping
Product typePT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use-
Target organism(s) (including development stage)Scientific name: BacteriaCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: VirusesCommon name: -Development stage: -
Field(s) of useIndoorDisinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
Application method(s)WipingProduct 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 frequencyReady-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 usersIndustrialProfessional
Pack sizes and packaging materialBottle: 250-1000 mlpackaging material: HDPE, surlyn/PPclosure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PP.canister: 5-10 Lpackaging material: HDPE.closure material is either: HDPE/LDPERevolver BAG: 1 Lpackaging material: EVAclosure material: PP/Silicone/EVA.
4.4.1.Use-specific instructions for useSpray 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 measuresThe 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 environmentSee 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 storageSee general directions for use.
5.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1. OF THE META SPC 15.1.Instructions for useClean 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 measuresThe 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 environmentFirst 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 storageShelf-life: 36 monthsKeep container tightly closed.Store in a well-ventilated place.Protect from sunlight.Store at room temperature in the original container.6.OTHER INFORMATIONThe 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 17.1.Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)Schülke® 6Market area: EU
Authorisation numberEU-0023860-0001 1-1
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Propan-2-olActive Substance67-63-0200-661-763,1
META SPC 21.META SPC 2 ADMINISTRATIVE INFORMATION1.1.Meta SPC 2 identifier
Identifiermeta-SPC 2
1.2.Suffix to the authorisation number
Number1-2
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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 2
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Propan-2-olActive Substance67-63-0200-661-763,163,1
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 statementsHighly flammable liquid and vapour.Causes serious eye irritation.May cause drowsiness or dizziness.Repeated exposure may cause skin dryness or cracking.
Precautionary statementsKeep 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 24.1.Use description
Table 5. Use # 1 – Disinfection of surfaces – wiping
Product typePT02 – 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: BacteriaCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -
Field(s) of useIndoorDisinfection 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)WipingProduct will be wiped directly on the surface.
Application rate(s) and frequencyReady-to-use wipesDisinfection after each production and cleaning process or when required according to SOP.
Category(ies) of usersIndustrialProfessional
Pack sizes and packaging materialSoft pack: 1-200 wipesPackaging material: LDPE/Alu/PET; LDPE/PET; biaxially oriented polypropylene (BOPP) + cast polypropylene (CPP)Pouch: 10-200 wipesPackaging material: LDPE/PETTub: 50-200 wipesPackaging material: HDPEClosure material is either PP, PE3385
4.1.1.Use-specific instructions for useThoroughly 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 measuresSee 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 environmentSee 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 storageSee general directions for use.
4.2.Use description
Table 6. Use # 2 – Disinfection of surfaces with food and feed contact – wiping
Product typePT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use-
Target organism(s) (including development stage)Scientific name: BacteriaCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: VirusesCommon name: -Development stage: -
Field(s) of useIndoorDisinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
Application method(s)WipingProduct will be wiped directly on the surface.
Application rate(s) and frequencyReady-to-use wipesDisinfection after each production and cleaning process or when required according to SOP.
Category(ies) of usersIndustrialProfessional
Pack sizes and packaging materialSoft pack: 1-200 wipesPackaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPPPouch: 10-200 wipesPackaging material: LDPE/PETTub: 50-200 wipesPackaging material: HDPEclosure material is either PP, PE3385
4.2.1.Use-specific instructions for useThoroughly 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 measuresSee 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 environmentSee 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 storageSee general directions for use.
5.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2. OF THE META SPC 25.1.Instructions for useClean 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 measuresThe 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 environmentFirst 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 storageShelf-life: 24 monthsKeep container tightly closed.Store in a well-ventilated place.Protect from sunlight.Store at room temperature in the original container.6.OTHER INFORMATIONThe 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 27.1.Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)Schülke® 7Market area: EU
Authorisation numberEU-0023860-0002 1-2
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Propan-2-olActive Substance67-63-0200-661-763,1
META SPC 31.META SPC 3 ADMINISTRATIVE INFORMATION1.1.Meta SPC 3 identifier
Identifiermeta-SPC 3
1.2.Suffix to the authorisation number
Number1-3
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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 3
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Propan-2-olActive Substance67-63-0200-661-763,163,1
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 statementsHighly flammable liquid and vapour.Causes serious eye irritation.May cause drowsiness or dizziness.Repeated exposure may cause skin dryness or cracking.
Precautionary statementsKeep 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 34.1.Use description
Table 7. Use # 1 – disinfection of surfaces – spraying
Product typePT02 – 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 tuberculosisCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -
Field(s) of useIndoorDisinfection 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)SprayingProduct will be sprayed directly on the surface
Application rate(s) and frequencyReady-to-use. Do not apply more than 25 ml/m2.Disinfection when required according to SOP.
Category(ies) of usersIndustrialProfessional
Pack sizes and packaging materialBottle: 250-1000 mlpackaging material: HDPE, surlyn/PPclosure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PPcanister: 5-10 Lpackaging material: HDPE.closure material is either: HDPE/LDPERevolver BAG: 1 Lpackaging material: EVAClosure: PP/Silicone/EVA
4.1.1.Use-specific instructions for useSpray 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 measuresThe 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 environmentSee 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 storageSee general directions for use
4.2.Use description
Table 8. Use # 2 – Disinfection of surfaces – wiping
Product typePT02 – 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 tuberculosisCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -
Field(s) of useIndoorDisinfection 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)WipingProduct 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 frequencyReady-to-use. Do not apply more than 25 ml/m2.Disinfection when required according to SOP.
Category(ies) of usersIndustrialProfessional
Pack sizes and packaging materialBottle: 250-1000 mlpackaging material: HDPE, surlyn/PPclosure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PPcanister: 5-10 Lpackaging material: HDPE.closure material is either: HDPE/LDPERevolver BAG: 1 Lpackaging material: EVAClosure: PP/Silicone/EVA
4.2.1.Use-specific instructions for useSpray 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 measuresThe 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 environmentSee 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 storageSee general directions for use
4.3.Use description
Table 9. Use # 3 – Disinfection of surfaces with food and feed contact – spraying
Product typePT04 – 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 tuberculosisCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: VirusesCommon name: -Development stage: -
Field(s) of useIndoorDisinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
Application method(s)SprayingProduct will be sprayed directly on the surface.
Application rate(s) and frequencyReady-to-use. Do not apply more than 25 ml/m2.Disinfection when required according to SOP.
Category(ies) of usersIndustrialProfessional
Pack sizes and packaging materialBottle: 250-1000 mlpackaging material: HDPE, surlyn/PPclosure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PPcanister: 5-10 Lpackaging material: HDPE.closure material is either: HDPE/LDPERevolver BAG: 1 Lpackaging material: EVAClosure: PP/Silicone/EVA
4.3.1.Use-specific instructions for useSpray 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 measuresThe 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 environmentSee 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 storageSee general directions for use
4.4.Use description
Table 10. Use # 4 – Disinfection of surfaces with food and feed contact – wiping
Product typePT04 – 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 tuberculosisCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: VirusesCommon name: -Development stage: -
Field(s) of useIndoorDisinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
Application method(s)WipingProduct 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 frequencyReady-to-use. Do not apply more than 25 ml/m2.Disinfection when required according to SOP.
Category(ies) of usersIndustrialProfessional
Pack sizes and packaging materialBottle: 250-1000 mlpackaging material: HDPE, surlyn/PPclosure material is either: PP, POM, LDPE, HDPE, PE, EVA, stainless steel, PBT, (LD)PE, exp. PTFE, LLDPE, EXPPE, Co Polymer PPcanister: 5-10 Lpackaging material: HDPE.closure material is either: HDPE/LDPERevolver BAG: 1 Lpackaging material: EVAClosure: PP/Silicone/EVA
4.4.1.Use-specific instructions for useSpray 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 measuresThe 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 environmentSee 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 storageSee general directions for use
5.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3. OF THE META SPC 35.1.Instructions for useClean 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 measuresThe 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 environmentFirst 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 storageShelf-life: 36 monthsKeep container tightly closed.Store in a well-ventilated place.Protect from sunlight.Store at room temperature in the original container.6.OTHER INFORMATIONThe 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 37.1.Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)Schülke® 8Market area: EU
Authorisation numberEU-0023860-0003 1-3
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Propan-2-olActive Substance67-63-0200-661-763,1
META SPC 41.META SPC 4 ADMINISTRATIVE INFORMATION1.1.Meta SPC 4 identifier
Identifiermeta-SPC 4
1.2.Suffix to the authorisation number
Number1-4
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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 4
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Propan-2-olActive Substance67-63-0200-661-763,163,1
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 statementsHighly flammable liquid and vapour.Causes serious eye irritation.May cause drowsiness or dizziness.Repeated exposure may cause skin dryness or cracking.
Precautionary statementsKeep 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 44.1.Use description
Table 11. Use # 1 – disinfection of surfaces – wiping
Product typePT02 – 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 tuberculosisCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -
Field(s) of useIndoorDisinfection 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)WipingProduct will be wiped directly on the surface.
Application rate(s) and frequencyReady-to-use wipes – -Disinfection when required according to SOP.
Category(ies) of usersIndustrialProfessional
Pack sizes and packaging materialSoft pack: 1-200 wipesPackaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPPPouch: 10-200 wipesPackaging material: LDPE/PETTub: 50-200 wipesPackaging material: HDPEclosure material is either PP, PE3385
4.1.1.Use-specific instructions for useThoroughly 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 measuresSee 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 environmentSee 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 storageSee general directions for use.
4.2.Use description
Table 12. Use # 2 – Disinfection of surfaces with food and feed contact – wiping
Product typePT04 – 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 tuberculosisCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: VirusesCommon name: -Development stage: -
Field(s) of useIndoorDisinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
Application method(s)WipingProduct will be wiped directly on the surface.
Application rate(s) and frequencyReady-to-use wipesDisinfection when required according to SOP.
Category(ies) of usersIndustrialProfessional
Pack sizes and packaging materialSoft pack: 1-200 wipesPackaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPPPouch: 10-200 wipesPackaging material: LDPE/PETTub: 50-200 wipesPackaging material: HDPEclosure material is either PP, PE3385
4.2.1.Use-specific instructions for useThoroughly 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 measuresSee 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 environmentSee 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 storageSee general directions for use.
5.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4. OF THE META SPC 45.1.Instructions for useClean 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 measuresThe 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 environmentFirst 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 storageShelf-life: 24 monthsKeep container tightly closed.Store in a well-ventilated place.Protect from sunlight.Store at room temperature in the original container.6.OTHER INFORMATIONThe 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 47.1.Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)Schülke® 9Market area: EU
Authorisation numberEU-0023860-0004 1-4
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Propan-2-olActive Substance67-63-0200-661-763,1
META SPC 51.META SPC 5 ADMINISTRATIVE INFORMATION1.1.Meta SPC 5 identifier
Identifiermeta-SPC 5
1.2.Suffix to the authorisation number
Number1-5
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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 5
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Propan-2-olActive Substance67-63-0200-661-763,163,1
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 statementsHighly flammable liquid and vapour.Causes serious eye irritation.May cause drowsiness or dizziness.Repeated exposure may cause skin dryness or cracking.
Precautionary statementsKeep 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 54.1.Use description
Table 13. Use # 1 – Disinfection of surfaces – wiping
Product typePT02 – 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 tuberculosisCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -
Field(s) of useIndoorDisinfection 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)WipingProduct will be wiped directly on the surface.
Application rate(s) and frequencyReady-to-use wipes
Category(ies) of usersIndustrialProfessional
Pack sizes and packaging materialSoft pack: 1-200 wipesPackaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPPPouch: 10-200 wipesPackaging material: LDPE/PETTub: 50-200 wipesPackaging material: HDPEclosure material is either PP, PE3385
4.1.1.Use-specific instructions for useThoroughly 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 measuresSee 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 environmentSee 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 storageSee general directions for use.
4.2.Use description
Table 14. Use # 2 – Disinfection of surfaces with food and feed contact – wiping
Product typePT04 – 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 tuberculosisCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: VirusesCommon name: -Development stage: -
Field(s) of useIndoorDisinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
Application method(s)WipingProduct will be wiped directly on the surface.
Application rate(s) and frequencyReady-to-use wipes
Category(ies) of usersIndustrialProfessional
Pack sizes and packaging materialSoft pack: 1-200 wipesPackaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPPPouch: 10-200 wipesPackaging material: LDPE/PETTub: 50-200 wipesPackaging material: HDPEclosure material is either PP, PE3385
4.2.1.Use-specific instructions for useThoroughly 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 measuresSee 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 environmentSee 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 storageSee general directions for use.
5.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 5. OF THE META SPC 55.1.Instructions for useClean 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 measuresThe 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 environmentFirst 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 storageShelf-life: 24 monthsKeep container tightly closed.Store in a well-ventilated place.Protect from sunlight.Store at room temperature in the original container.6.OTHER INFORMATIONThe 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 57.1.Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)Schülke® 10Market area: EU
Authorisation numberEU-0023860-0005 1-5
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Propan-2-olActive Substance67-63-0200-661-763,1
META SPC 61.META SPC 6 ADMINISTRATIVE INFORMATION1.1.Meta SPC 6 identifier
Identifiermeta-SPC6 kodan wipes IPA
1.2.Suffix to the authorisation number
Number1-6
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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 6
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Propan-2-olActive Substance67-63-0200-661-763,163,1
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 statementsHighly flammable liquid and vapour.Causes serious eye irritation.May cause drowsiness or dizziness.Repeated exposure may cause skin dryness or cracking.
Precautionary statementsIf 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 64.1.Use description
Table 15. Use # 1 – Disinfection of surfaces – wiping
Product typePT02 – 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 tuberculosisCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -
Field(s) of useIndoorDisinfection 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)WipingProduct will be wiped directly on the surface.
Application rate(s) and frequencyReady-to-use wipes
Category(ies) of usersIndustrialProfessionalGeneral public (non-professional)
Pack sizes and packaging materialSoft pack: 1-200 wipesPackaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPPPouch: 10-200 wipesPackaging material: LDPE/PETTub: 50-200 wipesPackaging material: HDPEclosure material is either PP, PE3385
4.1.1.Use-specific instructions for useThoroughly 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 measuresSee 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 environmentSee 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 storageSee general directions for use.
4.2.Use description
Table 16. Use # 2 – Disinfection of surfaces with food and feed contact – wiping
Product typePT04 – 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 tuberculosisCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: VirusesCommon name: -Development stage: -
Field(s) of useIndoorDisinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
Application method(s)WipingProduct will be wiped directly on the surface.
Application rate(s) and frequencyReady-to-use wipes
Category(ies) of usersIndustrialProfessionalGeneral public (non-professional)
Pack sizes and packaging materialSoft pack: 1-200 wipesPackaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPPPouch: 10-200 wipesPackaging material: LDPE/PETTub: 50-200 wipesPackaging material: HDPEclosure material is either PP, PE3385
4.2.1.Use-specific instructions for useThoroughly 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 measuresSee 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 environmentSee 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 storageSee general directions for use.
5.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 6. OF THE META SPC 65.1.Instructions for useClean 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 measuresThe 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 environmentFirst 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 storageShelf-life: 24 monthsKeep container tightly closed.Store in a well-ventilated place.Protect from sunlight.Store at room temperature in the original container.6.OTHER INFORMATIONThe 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 67.1.Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)Schülke® 11Market area: EU
Authorisation numberEU-0023860-0006 1-6
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Propan-2-olActive Substance67-63-0200-661-763,1
META SPC 71.META SPC 7 ADMINISTRATIVE INFORMATION1.1.Meta SPC 7 identifier
Identifiermeta-SPC7
1.2.Suffix to the authorisation number
Number1-7
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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 7
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Propan-2-olActive Substance67-63-0200-661-763,163,1
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 statementsHighly flammable liquid and vapour.Causes serious eye irritation.May cause drowsiness or dizziness.Repeated exposure may cause skin dryness or cracking.
Precautionary statementsKeep 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 74.1.Use description
Table 17. Use # 1 – Disinfection of surfaces – spraying
Product typePT02 – 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: BacteriaCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -
Field(s) of useIndoorDisinfection 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)SprayingProduct will be sprayed directly on the surface.
Application rate(s) and frequencyReady-to-use. Do not apply more than 25 ml/m2.
Category(ies) of usersIndustrialProfessional
Pack sizes and packaging materialBottle: 125-1000 mlpackaging material: HDPEClack 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 useSpray 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 measuresThe 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 environmentSee 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 storageSee general directions for use.
4.2.Use description
Table 18. Use # 2 – disinfection of surfaces – wiping
Product typePT02 – 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: BacteriaCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -
Field(s) of useIndoorDisinfection 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)WipingProduct 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 frequencyReady-to-use. Do not apply more than 25 ml/m2.
Category(ies) of usersIndustrialProfessional
Pack sizes and packaging materialBottle: 125-1000 mlpackaging material: HDPEClack cap material: PPFine 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 Lpackaging material: HDPEclosure material: HDPE
4.2.1.Use-specific instructions for useApply 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 measuresThe 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 environmentSee 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 storageSee general directions for use.
4.3.Use description
Table 19. Use # 3 – Disinfection of surfaces with food and feed contact – spraying
Product typePT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use-
Target organism(s) (including development stage)Scientific name: BacteriaCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: VirusesCommon name: -Development stage: -
Field(s) of useIndoorDisinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
Application method(s)SprayingProduct will be sprayed directly on the surface.
Application rate(s) and frequencyReady-to-use. Do not apply more than 25 ml/m2.-
Category(ies) of usersIndustrialProfessional
Pack sizes and packaging materialBottle: 125-1000 mlpackaging material: HDPEClack cap material: PPFine 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 useSpray 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 measuresThe 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 environmentSee 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 storageSee general directions for use.
4.4.Use description
Table 20. Use # 4 – Disinfection of surfaces with food and feed contact – wiping
Product typePT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use-
Target organism(s) (including development stage)Scientific name: BacteriaCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: VirusesCommon name: -Development stage: -
Field(s) of useIndoorDisinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
Application method(s)WipingProduct 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 frequencyReady-to-use. Do not apply more than 25 ml/m2.
Category(ies) of usersIndustrialProfessional
Pack sizes and packaging materialBottle: 125-1000 mlpackaging material: HDPEClack cap material: PPFine 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 Lpackaging material: HDPEclosure material: HDPE
4.4.1.Use-specific instructions for useApply 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 measuresThe 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 environmentSee 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 storageSee general directions for use.
5.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 7. OF THE META SPC 75.1.Instructions for useClean 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 measuresThe 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 environmentFirst 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 storageShelf-life: 36 monthsKeep container tightly closed.Store in a well-ventilated place.Protect from sunlight.Store at room temperature in the original container.6.OTHER INFORMATIONThe 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 77.1.Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)Superficid®Desocid rapidNeoseptin rapidNovosept rapidNovoseptin rapidLyorthol rapidCosmo rapidFordesin rapidSaltero rapidProp70 rapidAldovet rapidVetfarm rapidMDI rapidAntiseptica rapidSterisol SurfaceMENNO® I-QUICK plusMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EU
Authorisation numberEU-0023860-0007 1-7
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Propan-2-olActive Substance67-63-0200-661-763,1
7.2.Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)Superficid® pureDesocid rapid pureNeoseptin rapid pureNovosept rapid pureNovoseptin rapid pureLyorthol rapid pureCosmo rapid pureFordesin rapid pureSaltero rapid pureProp70 rapid pureAldovet rapid pureVetfarm rapid pureMDI rapid pureAntiseptica rapid pureSterisol Surface pureBTS 6000MENNO® I-QUICKEWA® DES readyKiehl-RapinolDes AMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EU
Authorisation numberEU-0023860-0008 1-7
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Propan-2-olActive Substance67-63-0200-661-763,1
META SPC 81.META SPC 8 ADMINISTRATIVE INFORMATION1.1.Meta SPC 8 identifier
Identifiermeta-SPC8
1.2.Suffix to the authorisation number
Number1-8
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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 8
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Propan-2-olActive Substance67-63-0200-661-763,163,1
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 statementsHighly flammable liquid and vapour.Causes serious eye irritation.May cause drowsiness or dizziness.Repeated exposure may cause skin dryness or cracking.
Precautionary statementsKeep 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 84.1.Use description
Table 21. Use # 1 – Disinfection of surfaces – wiping
Product typePT02 – 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: BacteriaCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -
Field(s) of useIndoorDisinfection 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)WipingProduct will be wiped directly on the surface.
Application rate(s) and frequencyReady-to-use wipes
Category(ies) of usersIndustrialProfessional
Pack sizes and packaging materialCan: 100-150 wipesPackaging: HDPEClosure material: HDPEPack: 100-150 wipesPackaging: PET/PE
4.1.1.Use-specific instructions for useThoroughly 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 measuresSee 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 environmentSee 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 storageSee general directions for use.
4.2.Use description
Table 22. Use # 2 – Disinfection of surfaces with food and feed contact – wiping
Product typePT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use-
Target organism(s) (including development stage)Scientific name: BacteriaCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: VirusesCommon name: -Development stage: -
Field(s) of useIndoorDisinfection of clean non-porous surfaces in kitchens and food industry including cleanrooms (class A/B)
Application method(s)WipingProduct will be wiped directly on the surface.
Application rate(s) and frequencyReady-to-use wipes
Category(ies) of usersIndustrialProfessional
Pack sizes and packaging materialCan: 100-150 wipesPackaging: HDPEClosure material: HDPEPack: 100-150 wipesPackaging: PET/PE
4.2.1.Use-specific instructions for useThoroughly 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 measuresSee 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 environmentSee 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 storageSee general directions for use.
5.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 8. OF THE META SPC 85.1.Instructions for useClean 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 measuresThe 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 environmentFirst 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 storageShelf-life: 24 monthsKeep container tightly closed.Store in a well-ventilated place.Protect from sunlight.Store at room temperature in the original container.6.OTHER INFORMATIONThe 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 87.1.Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)Descorapid® TücherDesocid TücherNeoseptin TücherNovosept TücherNovoseptin TücherLyorthol TücherCosmo TücherFordesin TücherSaltero TücherProp70 TücherManosafe TücherDermoguard TücherDermosafe TücherAldovet TücherVetfarm TücherMDI TücherAntiseptica TücherAntiseptica wipesMENNO®WIPDescorapid® wipesDesocid wipesNeoseptin wipesNovosept wipesNovoseptin wipesLyorthol wipesCosmo wipesFordesin wipesSaltero wipesProp70 wipesManosafe wipesDermoguard wipesDermosafe wipesAldovet wipesVetfarm wipesMDI wipesMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EU
Authorisation numberEU-0023860-0009 1-8
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Propan-2-olActive Substance67-63-0200-661-763,1
7.2.Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)Superficid® pure wipesDesocid rapid pure wipesNeoseptin rapid pure wipesNovosept rapid pure wipesNovoseptin rapid pure wipesLyorthol rapid pure wipesCosmo rapid pure wipesFordesin rapid pure wipesSaltero rapid pure wipesProp70 rapid pure wipesAldovet rapid pure wipesVetfarm rapid pure wipesMDI rapid pure wipesAntiseptica rapid pure wipesMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EUMarket area: EU
Authorisation numberEU-0023860-0010 1-8
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Propan-2-olActive Substance67-63-0200-661-763,1