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)
Commission Implementing Regulation (EU) 2023/2087of 28 September 2023granting 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 productsOJ L 167, 27.6.2012, p. 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 414/2013Commission 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 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 opinionECHA opinion for "Lysoform IPA Surface", 31 March 2023, https://echa.europa.eu/opinions-on-union-authorisation. 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 354/2013Commission 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)., 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 1A 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 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, 28 September 2023.For the CommissionThe PresidentUrsula von der LeyenANNEXSummary of product characteristics for a biocidal product familyLysoform IPA SurfaceProduct 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-0030790-0000R4BP asset number: EU-0030790-0000PART IFIRST INFORMATION LEVEL1.ADMINISTRATIVE INFORMATION1.1.Family name
NameLysoform 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 holderNameLysoform Dr Hans Rosemann GmbH
AddressKaiser-Wilhelm-Str. 133, 12247 Berlin Germany
Authorisation numberEU-0030790-0000
R4BP asset numberEU-0030790-0000
Date of the authorisation19 October 2023
Expiry date of the authorisation30 November 2030
1.4.Manufacturer(s) of the biocidal products
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 manufacturerImeco
Address of manufacturerBoschstr. 5, 63768 Hösbach Germany
Location of manufacturing sitesBoschstr. 5, 63768 Hösbach GermanyNeue Straße 2-4, 09471 Köningswalde Germany
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 manufacturerSterisol AB
Address of manufacturerKronoängsgatan 3, 592 23 Vadstena Sweden
Location of manufacturing sitesKronoängsgatan 3, 592 23 Vadstena Sweden
Name of manufacturerWHR GmbH
Address of manufacturerAm Galgenturm 2, 97638 Mellrichstadt Germany
Location of manufacturing sitesAm Galgenturm 2, 97638 Mellrichstadt Germany
Name of manufacturerHygan GmbH | Srl
Address of manufacturerMeucci-Str. 5, 39055 Leifers | Laives (BZ) Italy
Location of manufacturing sitesMeucci-Str. 5, 39055 Leifers | Laives (BZ) Italy
Name of manufacturerLaboratoire Sarbec SA
Address of manufacturer10 rue du Vertuquet, 59960 Neuville-en-Ferrain France
Location of manufacturing sites10 rue du Vertuquet, 59960 Neuville-en-Ferrain France
Name of manufacturerDr Schumacher GmbH
Address of manufacturerAm Roggenfeld 3, 34323 Malsfeld Germany
Location of manufacturing sitesAm Roggenfeld 3, 34323 Malsfeld GermanyJeleniogórska 12, 59-800 Lubań Poland
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
IdentifierSuperficid®
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 to/container to an approved waste disposal plant.
4.AUTHORISED USE(S) OF THE META SPC 14.1.Use description
Table 1Use # 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)Method: SprayingDetailed description:Product will be sprayed directly on the surface.
Application rate(s) and frequencyApplication Rate: Ready-to-use. Do not apply more than 25 ml/m2.Dilution (%): -Number and timing of application:-
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 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 2Use # 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)Method: WipingDetailed 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 frequencyApplication Rate: Ready-to-use. Do not apply more than 25 ml/m2.Dilution (%): -Number and timing of application:-
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 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 3Use # 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)Method: SprayingDetailed description:Product will be sprayed directly on the surface.
Application rate(s) and frequencyApplication Rate: Ready-to-use. Do not apply more than 25 ml/m2.Dilution (%): -Number and timing of application:-
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 (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 packaging4.3.5.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 4Use # 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)Method: WipingDetailed 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 frequencyApplication Rate: Ready-to-use. Do not apply more than 25 ml/m2.Dilution (%): -Number and timing of application:-
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 packaging4.4.5.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)Superficid®Market area: EU
Desocid rapidMarket area: EU
Neoseptin rapidMarket area: EU
Novosept rapidMarket area: EU
Novoseptin rapidMarket area: EU
Lyorthol rapidMarket area: EU
Cosmo rapidMarket area: EU
Fordesin rapidMarket area: EU
Saltero rapidMarket area: EU
Prop70 rapidMarket area: EU
Aldovet rapidMarket area: EU
Vetfarm rapidMarket area: EU
MDI rapidMarket area: EU
Antiseptica rapidMarket area: EU
Sterisol SurfaceMarket area: EU
MENNO® I-QUICK plusMarket area: EU
Authorisation numberEU-0030790-0001 1-1
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® pureMarket area: EU
Desocid rapid pureMarket area: EU
Neoseptin rapid pureMarket area: EU
Novosept rapid pureMarket area: EU
Novoseptin rapid pureMarket area: EU
Lyorthol rapid pureMarket area: EU
Cosmo rapid pureMarket area: EU
Fordesin rapid pureMarket area: EU
Saltero rapid pureMarket area: EU
Prop70 rapid pureMarket area: EU
Aldovet rapid pureMarket area: EU
Vetfarm rapid pureMarket area: EU
MDI rapid pureMarket area: EU
Antiseptica rapid pureMarket area: EU
Sterisol Surface pureMarket area: EU
BTS 6000Market area: EU
MENNO® I-QUICKMarket area: EU
EWA® DES readyMarket area: EU
Kiehl-RapinolMarket area: EU
Des AMarket area: EU
Authorisation numberEU-0030790-0002 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
IdentifierDescorapid®
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 to/container to an approved waste disposal plant.
4.AUTHORISED USE(S) OF THE META SPC 24.1.Use description
Table 5Use # 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)Method: WipingDetailed description:Product will be wiped directly on the surface.
Application rate(s) and frequencyApplication Rate: Ready-to-use wipesDilution (%): -Number and timing of application:-
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 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 6Use # 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)Method: WipingDetailed description:Product will be wiped directly on the surface.
Application rate(s) and frequencyApplication Rate: Ready-to-use wipesDilution (%): -Number and timing of application:-
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 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.
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)Descorapid® TücherMarket area: EU
Desocid TücherMarket area: EU
Neoseptin TücherMarket area: EU
Novosept TücherMarket area: EU
Novoseptin TücherMarket area: EU
Lyorthol TücherMarket area: EU
Cosmo TücherMarket area: EU
Fordesin TücherMarket area: EU
Saltero TücherMarket area: EU
Prop70 TücherMarket area: EU
Manosafe TücherMarket area: EU
Dermoguard TücherMarket area: EU
Dermosafe TücherMarket area: EU
Aldovet TücherMarket area: EU
Vetfarm TücherMarket area: EU
MDI TücherMarket area: EU
Antiseptica TücherMarket area: EU
Antiseptica wipesMarket area: EU
MENNO®WIPMarket area: EU
Descorapid® wipesMarket area: EU
Desocid wipesMarket area: EU
Neoseptin wipesMarket area: EU
Novosept wipesMarket area: EU
Novoseptin wipesMarket area: EU
Lyorthol wipesMarket area: EU
Cosmo wipesMarket area: EU
Fordesin wipesMarket area: EU
Saltero wipesMarket area: EU
Prop70 wipesMarket area: EU
Manosafe wipesMarket area: EU
Dermoguard wipesMarket area: EU
Dermosafe wipesMarket area: EU
Aldovet wipesMarket area: EU
Vetfarm wipesMarket area: EU
MDI wipesMarket area: EU
Antiseptica wipesMarket area: EU
Authorisation numberEU-0030790-0003 1-2
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 wipesMarket area: EU
Desocid rapid pure wipesMarket area: EU
Neoseptin rapid pure wipesMarket area: EU
Novosept rapid pure wipesMarket area: EU
Novoseptin rapid pure wipesMarket area: EU
Lyorthol rapid pure wipesMarket area: EU
Cosmo rapid pure wipesMarket area: EU
Fordesin rapid pure wipesMarket area: EU
Saltero rapid pure wipesMarket area: EU
Prop70 rapid pure wipesMarket area: EU
Aldovet rapid pure wipesMarket area: EU
Vetfarm rapid pure wipesMarket area: EU
MDI rapid pure wipesMarket area: EU
Antiseptica rapid pure wipesMarket area: EU
Authorisation numberEU-0030790-0004 1-2
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Propan-2-olActive Substance67-63-0200-661-763,1