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Commission Implementing Regulation (EU) 2024/2194 of 4 September 2024 amending Implementing Regulation (EU) 2020/1991 as regards administrative and minor changes to the Union authorisation for the biocidal product family perform-IPA

Commission Implementing Regulation (EU) 2024/2194of 4 September 2024amending Implementing Regulation (EU) 2020/1991 as regards administrative and minor changes to the Union authorisation for the biocidal product family perform-IPA(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; ELI: http://data.europa.eu/eli/reg/2012/528/oj., and in particular Article 50(2) thereof,Whereas:(1)On 27 November 2020, a Union authorisation with authorisation number EU-0023656-0000 was granted to Schülke & Mayr GmbH for the making available on the market and use of the biocidal product family "perform IPA" by Commission Implementing Regulation (EU) 2020/1991Commission Implementing Regulation (EU) 2020/1991 of 27 November 2020 granting a Union authorisation for the biocidal product family "perform-IPA" (OJ L 410, 7.12.2020, p. 1; ELI: http://data.europa.eu/eli/reg_impl/2020/1991/oj).. The Annex to that Implementing Regulation provides the summary of product characteristics ("SPC") for the biocidal product family "perform-IPA" in accordance with Article 22 of Regulation (EU) No 528/2012.(2)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; ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj). provides for the procedural rules for the different categories of changes referred to in Article 50(3) of Regulation (EU) No 528/2012. On receipt of an opinion from the European Chemicals Agency ("the Agency") on an application from an authorisation holder of a Union authorisation, seeking to change any of the information submitted for the initial application for authorisation, the Commission is to decide whether the conditions of Article 19 or, where relevant, Article 25 of Regulation (EU) No 528/2012 are still met and whether the terms and conditions of the authorisation are required to be amended.(3)On 20 December 2021, Schülke & Mayr GmbH submitted to the Agency a notification of administrative changes in accordance with Article 11(1) of Implementing Regulation (EU) No 354/2013, recorded in the register for biocidal products ("the Register") under case number BC-AB072184-64, and an application for a minor change in accordance with Article 12(1) of that Implementing Regulation, recorded in the Register under case number BC-SN072185-20, to the Union authorisation for the biocidal product family "perform-IPA". In respect of the administrative changes, Schülke & Mayr GmbH notified a change in the administrative details of two of the product formulators, the addition of five product formulators, the addition of a trade name in the section meta-SPC 1 of the SPC and the removal of a claim that products can be used in clean rooms class A/B in the sections meta-SPC 1 to 6 of the SPC. Regarding the minor change, Schülke & Mayr GmbH applied for a change of the pack-size range (all for the sections meta-SPC 1 and 3 of the SPC: extension of pack size range for canisters from 5-10 L to 5-30 L, addition of 200-220 L HDPE drums and addition of 900-1000 L containers (IBC)).(4)On 1 February 2023, Schülke & Mayr GmbH submitted to the Agency an application for a further minor change to the Union authorisation for the biocidal product family "perform-IPA" in accordance with Article 12(1) of Implementing Regulation (EU) No 354/2013, recorded in the Register under case number BC-NJ084251-38, for the addition of a claim for limited spectrum virucidal activity to all product-type 2 uses (disinfectants and algaecides not intended for direct application to humans and animals) in the sections meta-SPC 1 to 6 of the SPC.(5)On 11 February 2022, the Agency submitted an opinionECHA Opinion on the administrative change of the Union authorisation of the biocidal product family: perform-IPA of 11 February 2022, Opinion N° UAD-C-1560029-43-00/F, https://echa.europa.eu/opinions-on-union-authorisation. to the Commission on the notified administrative changes to the Union authorisation for the biocidal product family "perform-IPA", in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, together with a revised summary of the biocidal product characteristics. The opinion concludes that the proposed changes are administrative changes in accordance with Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 1 of the Annex to Implementing Regulation (EU) No 354/2013, and that after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 are still met. On 7 March 2022, the Agency transmitted to the Commission the revised summary of biocidal product characteristics of the Union authorisation for the biocidal product family "perform-IPA" in all official languages of the Union covering all administrative changes applied for, in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.(6)On 10 October 2023, the Agency submitted its opinionsBiocidal Products Committee (BPC) opinion on the minor change to the Union authorisation of the biocidal product family "perform-IPA", 10 October 2023, ECHA/BPC/397/2023 and BPC opinion on the minor change to the Union authorisation of the biocidal product family "perform-IPA", 10 October 2023, ECHA/BPC/400/2023, https://echa.europa.eu/opinions-on-union-authorisation. to the Commission on the two applications for minor changes to the Union authorisation for the biocidal product family "perform-IPA", in accordance with Article 12(4) of Implementing Regulation (EU) No 354/2013, together with a revised summary of the biocidal product characteristics and a revised assessment report concluding that the proposed changes are minor changes in accordance with Article 50(3), point (b), of Regulation (EU) No 528/2012 and as specified in Title 2 of the Annex to Implementing Regulation (EU) No 354/2013, and that after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 are still met.(7)On 10 November 2023, the Agency transmitted to the Commission the revised summary of biocidal product characteristics of the Union authorisation for the biocidal product family "perform-IPA" in all official languages of the Union covering all administrative and minor changes applied for, in accordance with Article 12(6) of Implementing Regulation (EU) No 354/2013.(8)The Commission concurs with the opinions of the Agency and therefore considers it appropriate to amend the Union authorisation for the biocidal product family "perform-IPA" to introduce the administrative and minor changes requested by Schülke & Mayr GmbH.(9)Except for the amendments regarding the administrative and minor changes, all other information included in the summary of the biocidal product characteristics of "perform-IPA" as set out in the Annex to Implementing Regulation (EU) 2020/1991 remains unchanged.(10)In order to enhance clarity and to ease the access of users and interested parties to the final consolidated version of the summary of biocidal product characteristics which is to be published by the Agency, the Annex to Implementing Regulation (EU) 2020/1991 should be replaced in its entirety.(11)Implementing Regulation (EU) 2020/1991 should therefore be amended accordingly,HAS ADOPTED THIS REGULATION:

Article 1The Annex to Implementing Regulation (EU) 2020/1991 is replaced by the text in the Annex to this Regulation.

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, 4 September 2024.For the CommissionThe PresidentUrsula von der LeyenANNEXSummary of product characteristics for a biocidal product familyperform-IPAProduct 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-0023656-0000R4BP asset number: EU-0023656-0000PART IFIRST INFORMATION LEVEL1.ADMINISTRATIVE INFORMATION1.1.Family name

Name	perform-IPA

1.2.Product type(s)

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)PT04 - Food and feed area (Disinfectants)

1.3.Authorisation holder

Name and address of the authorisation holder	Name	Schuelke & Mayr GmbH
	Address	Robert-Koch-Str. 2, 22851 Norderstedt Germany
Authorisation number	EU-0023656-0000
R4BP asset number	EU-0023656-0000
Date of the authorisation	27 December 2020
Expiry date of the authorisation	30 November 2030

1.4.Manufacturer(s) of the biocidal products

Name of manufacturer	Schülke & Mayr GmbH
Address of manufacturer	Robert-Koch-Str. 2, 22851 Norderstedt Germany
Location of manufacturing sites	Robert-Koch-Str. 2, 22851 Norderstedt Germany

Name of manufacturer	BOCHEMIE a.s.
Address of manufacturer	Lidická 326, 735 95 Bohumín Czech Republic
Location of manufacturing sites	Lidická 326, 735 95 Bohumín Czech Republic

Name of manufacturer	Imeco
Address of manufacturer	Am Sägewerk 10, 63773 Goldbach Germany
Location of manufacturing sites	Boschstr. 5, 63768 Hösbach GermanyNeue Straße 2-4, 09471 Köningswalde GermanyAm Gansberg 9, 09481 Elterlein Germanyul.Wlo'kiennicza 10, 59-800 Luban Poland

Name of manufacturer	Tristel Solutions Limited
Address of manufacturer	Lynx Business Park, Fordham Road, Snailwell, CB8 7NY Cambridgeshire United Kingdom
Location of manufacturing sites	Lynx Business Park, Fordham Road, Snailwell, CB8 7NY Cambridgeshire United Kingdom

Name of manufacturer	Techtex
Address of manufacturer	Units 7&8 Rhodes Bus. Park Silburn Way, M24 4NE Middleton United Kingdom
Location of manufacturing sites	Units 7&8 Rhodes Bus. Park Silburn Way, M24 4NE Middleton United Kingdom

Name of manufacturer	A.F.P. GmbH
Address of manufacturer	Otto Brenner Straße 16, 21337 Lüneburg Germany
Location of manufacturing sites	Otto Brenner Straße 16, 21337 Lüneburg Germany

Name of manufacturer	Innovate GmbH
Address of manufacturer	Gewerbegebietsstraße 30, 06618 Schönburg Germany
Location of manufacturing sites	Gewerbegebietsstraße 30, 06618 Schönburg GermanyKeizersveld 99, 5803 AP Venray Netherlands

Name of manufacturer	Lysoform Dr. Hans Rosemann GmbH
Address of manufacturer	Kaiser-Wilhelm-Straße 133, 12247 Berlin Germany
Location of manufacturing sites	Kaiser-Wilhelm-Straße 133, 12247 Berlin Germany

Name of manufacturer	Sterisol AB
Address of manufacturer	Kronoängsgatan 3, 592 23 Vadstena Sweden
Location of manufacturing sites	Kronoängsgatan 3, 592 23 Vadstena Sweden

Name of manufacturer	Rudolf Dankwardt GmbH
Address of manufacturer	Gutenbergring 50-52, 22848 Norderstedt Germany
Location of manufacturing sites	Gutenbergring 50-52, 22848 Norderstedt GermanyLagerstr. 15, 19249 Jessenitz - Werk / Lübtheen Germany

Name of manufacturer	BIOXAL SA
Address of manufacturer	ZI Sud Secteur A, Route des Varennes, 71100 Chalon sur Saône France
Location of manufacturing sites	ZI Sud Secteur A, Route des Varennes, 71100 Chalon sur Saône France

Name of manufacturer	Lichtenheldt GmbH
Address of manufacturer	Industriestrasse 7-9, 23812 Wahlstedt Germany
Location of manufacturing sites	Industriestrasse 7-9, 23812 Wahlstedt GermanyJustus-Liebig-Weg 1, 23812 Wahlstedt Germany

Name of manufacturer	NATURELLE CONSUMER PRODUCTS LTD
Address of manufacturer	Unit 5 Bankmore Way, East industrial Park,, BT79 ONZ Doogary, Omagh, Co. Tyrone United Kingdom
Location of manufacturing sites	Unit 5 Bankmore Way, East industrial Park,, BT79 ONZ Doogary, Omagh, Co. Tyrone United Kingdom

Name of manufacturer	Halag Chemie AG
Address of manufacturer	Weiernstrasse 30, 8355 Aadorf Switzerland
Location of manufacturing sites	Weiernstrasse 30, 8355 Aadorf Switzerland

Name of manufacturer	PDI (EMEA) Ltd
Address of manufacturer	Pywell Rd Willowbrook East Industrial Estate, NN17 5XJ Corby United Kingdom
Location of manufacturing sites	Pywell Rd Willowbrook East Industrial Estate, NN17 5XJ Corby United Kingdom

1.5.Manufacturer(s) of the active substance(s)

Active substance	Propan-2-ol
Name of manufacturer	Ineos Solvents Germany GmbH (formerly Sasol)
Address of manufacturer	Römerstraße 733, 47443 Moers Germany
Location of manufacturing sites	Römerstraße 733, 47443 Moers GermanyShamrockstr. 88, 44643 Herne Germany

Active substance	Propan-2-ol
Name of manufacturer	Shell Chemicals Europe B.V.
Address of manufacturer	Postbus 2334, 3000 CH Rotterdam Netherlands
Location of manufacturing sites	Shell Nederland Raffinaderij B.V., Vondelingenweg 601, 3196 KK Rotterdam-Pernis Netherlands

2.PRODUCT FAMILY COMPOSITION AND FORMULATION2.1.Qualitative and quantitative information on the composition of the family

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Propan-2-ol		Active Substance	67-63-0	200-661-7	63,1	63,1

2.2.Type(s) of formulation

Formulation(s)

Any other liquid (AL), ready-to-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

Identifier

meta SPC 1 perform IPA liquid

1.2.Suffix to the authorisation number

Number

1-1

1.3.Product type(s)

Product type(s)

PT04 - Food and feed area (Disinfectants)PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

2.META SPC 1 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 1

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Propan-2-ol		Active Substance	67-63-0	200-661-7	63,1	63,1

2.2.Type(s) of formulation of the meta SPC 1

Formulation(s)

Any other liquid (AL), ready-to-use

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements

Highly flammable liquid and vapour.Causes serious eye irritation.May cause drowsiness or dizziness.Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.Keep container tightly closed.Ground and bond container and receiving equipment.Use explosion-proof electrical/ventilating/lighting equipment.Use non-sparking tools.Take action to prevent static discharges.Avoid breathing vapours.Avoid breathing spray.Use only outdoors or in a well-ventilated area.Wear eye protection.IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.Call a POISON CENTER or doctor if you feel unwell.If eye irritation persists:Get medical advice.If eye irritation persists:Get medical attention.In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.Store in a well-ventilated place.Keep cool.Store locked up.Dispose of contents to /container to an approved waste disposal plant.

4.AUTHORISED USE(S) OF THE META SPC 14.1.Use description

Table 1Use # 1 – Disinfection of surfaces - spraying

Product type	PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: BacteriaCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: viruses (limited spectrum virucidal activity)Common name: -Development stage: -
Field(s) of use	IndoorDisinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas
Application method(s)	Method: SprayingDetailed description:Product will be sprayed directly on the surface
Application rate(s) and frequency	Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.Dilution (%): -Number and timing of application:Disinfection after each production and cleaning process or when required according to standard operating procedure (SOP)
Category(ies) of users	IndustrialProfessional
Pack sizes and packaging material	Bottle: 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: 5-30 litrepackaging material: HDPE.closure material is either: HDPE/LDPERevolver BAG: 1 litrepackaging material: EVAclosure material: PP/Silicone/EVAdrum: 200 - 220 litrepackaging material: HDPEclosure material is either: PPIBC: 900-1000 litrepackaging material: HDPE with steel frameclosure material is either: PP, HDPE

4.1.1.Use-specific instructions for useSpray ready-to-use product on the surface and allow to take effect at 20± 2°C for at least 1 minute (bactericidal and yeasticidal activity) or 2 minutes (limited spectrum virucidal activity).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 type	PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: BacteriaCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: viruses (limited spectrum virucidal activity)Common name: -Development stage: -
Field(s) of use	IndoorDisinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas
Application method(s)	Method: WipingDetailed description:Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on the surface.
Application rate(s) and frequency	Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.Dilution (%): -Number and timing of application:Disinfection after each production and cleaning process or when required according to SOP.
Category(ies) of users	IndustrialProfessional
Pack sizes and packaging material	Bottle: 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: 5-30 litrepackaging material: HDPE.closure material is either: HDPE/LDPERevolver BAG: 1 litrepackaging material: EVAclosure material: PP/Silicone/EVA.drum: 200 - 220 litrepackaging material: HDPEclosure material is either: PPIBC: 900-1000 litrepackaging material: HDPE with steel frameclosure material is either: PP, HDPE

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 at 20 ± 2°C for at least 5 minutes (bactericidal, yeasticidal and limited spectrum virucidal activity).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 type	PT04 - 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 use	IndoorDisinfection of clean non-porous surfaces in kitchens and food industry
Application method(s)	Method: SprayingDetailed description:Product will be sprayed directly on the surface.
Application rate(s) and frequency	Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.Dilution (%): -Number and timing of application:Disinfection after each production and cleaning process or when required according to SOP.
Category(ies) of users	IndustrialProfessional
Pack sizes and packaging material	Bottle: 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: 5-30 litrepackaging material: HDPE.closure material is either: HDPE/LDPERevolver BAG: 1 litrepackaging material: EVAclosure material: PP/Silicone/EVA.drum: 200 - 220 litrepackaging material: HDPEclosure material is either: PPIBC: 900-1000 litrepackaging material: HDPE with steel frameclosure material is either: PP, HDPE

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 (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 type	PT04 - 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 use	IndoorDisinfection of clean non-porous surfaces in kitchens and food industry
Application method(s)	Method: WipingDetailed description:Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on the surface.
Application rate(s) and frequency	Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.Dilution (%): -Number and timing of application:Disinfection after each production and cleaning process or when required according to SOP.
Category(ies) of users	IndustrialProfessional
Pack sizes and packaging material	Bottle: 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: 5-30 litrepackaging material: HDPE.closure material is either: HDPE/LDPERevolver BAG: 1 litrepackaging material: EVAclosure material: PP/Silicone/EVA.drum: 200 - 220 litrepackaging material: HDPE closure material is either: PPIBC: 900-1000 litrepackaging material: HDPE with steel frame closure material is either: PP, HDPE

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 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)	perform® sterile alcohol IPA		Market area: EU
	perform® classic alcohol IPA		Market area: EU
	buraton® IPA		Market area: EU
	perform® advanced alcohol IPA		Market area: EU
	arcana® IPA		Market area: EU
	clear IPA		Market area: EU
	pure IPA		Market area: EU
	disinfectant IPA		Market area: EU
	Surface disinfection liquid classic		Market area: EU
	sterile IPA		Market area: EU
	mikrozid® sterile liquid		Market area: EU
	Surface disinfection liquid sterile		Market area: EU
	BTS 6000		Market area: EU
	Halades Alco		Market area: EU
Authorisation number	EU-0023656-0001 1-1
Common name	IUPAC name	Function		CAS number	EC number	Content (%)
Propan-2-ol		Active Substance		67-63-0	200-661-7	63,1

META SPC 21.META SPC 2 ADMINISTRATIVE INFORMATION1.1.Meta SPC 2 identifier

Identifier

meta SPC 2 perform wipes IPA

1.2.Suffix to the authorisation number

Number

1-2

1.3.Product type(s)

Product type(s)

PT04 - Food and feed area (Disinfectants)PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

2.META SPC 2 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 2

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Propan-2-ol		Active Substance	67-63-0	200-661-7	63,1	63,1

2.2.Type(s) of formulation of the meta SPC 2

Formulation(s)

Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

Hazard statements

Highly flammable liquid and vapour.Causes serious eye irritation.May cause drowsiness or dizziness.Repeated exposure may cause skin dryness or cracking.

Precautionary statements

4.AUTHORISED USE(S) OF THE META SPC 24.1.Use description

Table 5Use # 1 – Disinfection of surfaces - wiping

Product type	PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: BacteriaCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: viruses (limited spectrum virucidal activity)Common name: -Development stage: -
Field(s) of use	IndoorDisinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas
Application method(s)	Method: WipingDetailed description:Product will be wiped directly on the surface.
Application rate(s) and frequency	Application Rate: Ready-to-use wipesDilution (%): -Number and timing of application:Disinfection after each production and cleaning process or when required according to SOP.
Category(ies) of users	IndustrialProfessional
Pack sizes and packaging material	Soft pack: 1-200 wipesPackaging material: LDPE/Alu/PET; LDPE/PET; biaxially oriented polypropylene (BOPP) + cast polypropylene (CPP)Pouch: 10-200 wipesPackaging material: LDPE/PETTube: 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 at 20 ± 2°C for at least 5 minutes (bactericidal, yeasticidal and limited spectrum virucidal activity).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 type	PT04 - 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 use	IndoorDisinfection of clean non-porous surfaces in kitchens and food industry
Application method(s)	Method: WipingDetailed description:Product will be wiped directly on the surface.
Application rate(s) and frequency	Application Rate: Ready-to-use wipesDilution (%): -Number and timing of application:Disinfection after each production and cleaning process or when required according to SOP.
Category(ies) of users	IndustrialProfessional
Pack sizes and packaging material	Soft pack: 1-200 wipesPackaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPPPouch: 10-200 wipesPackaging material: LDPE/PETTube: 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 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)	perform classic wipes IPA		Market area: EU
	buraton® wipes IPA		Market area: EU
	perform® advanced wipes IPA		Market area: EU
	arcana® wipes IPA		Market area: EU
	clear IPA wipes		Market area: EU
	pure IPA wipes		Market area: EU
	disinfectant IPA wipes		Market area: EU
	Surface disinfection wipes classic		Market area: EU
	perform® sterile wipes IPA		Market area: EU
	sterile IPA wipes		Market area: EU
	mikrozid® sterile wipes		Market area: EU
	Surface disinfection wipes sterile		Market area: EU
Authorisation number	EU-0023656-0002 1-2
Common name	IUPAC name	Function		CAS number	EC number	Content (%)
Propan-2-ol		Active Substance		67-63-0	200-661-7	63,1

META SPC 31.META SPC 3 ADMINISTRATIVE INFORMATION1.1.Meta SPC 3 identifier

Identifier

meta SPC 3 mikrozid liquid

1.2.Suffix to the authorisation number

Number

1-3

1.3.Product type(s)

Product type(s)

PT04 - Food and feed area (Disinfectants)PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

2.META SPC 3 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 3

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Propan-2-ol		Active Substance	67-63-0	200-661-7	63,1	63,1

2.2.Type(s) of formulation of the meta SPC 3

Formulation(s)

Any other liquid (AL), ready-to-use

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

Hazard statements

Highly flammable liquid and vapour.Causes serious eye irritation.May cause drowsiness or dizziness.Repeated exposure may cause skin dryness or cracking.

Precautionary statements

4.AUTHORISED USE(S) OF THE META SPC 34.1.Use description

Table 7Use # 1 – Disinfection of surfaces - spraying

Product type	PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: Bacteria including Mycobacterium tuberculosisCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: viruses (limited spectrum virucidal activity)Common name: -Development stage: -
Field(s) of use	IndoorDisinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas
Application method(s)	Method: SprayingDetailed description:Product will be sprayed directly on the surface
Application rate(s) and frequency	Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.Dilution (%): -Number and timing of application:Disinfection when required according to SOP.
Category(ies) of users	IndustrialProfessional
Pack sizes and packaging material	Bottle: 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: 5-30 litrepackaging material: HDPE.closure material is either: HDPE/LDPERevolver BAG: 1 litrepackaging material: EVAClosure : PP/Silicone/EVAdrum: 200 - 220 litrepackaging material: HDPEclosure material is either: PPIBC:900-1000 litrepackaging material: HDPE with steel frame closure material is either: PP, HDPE

Table 8Use # 2 – Disinfection of surfaces - wiping

Product type	PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: Bacteria including Mycobacterium tuberculosisCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: viruses (limited spectrum virucidal activity)Common name: -Development stage: -
Field(s) of use	IndoorDisinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas
Application method(s)	Method: WipingDetailed description:Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on the surface.
Application rate(s) and frequency	Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.Dilution (%): -Number and timing of application:Disinfection when required according to SOP.
Category(ies) of users	IndustrialProfessional
Pack sizes and packaging material	Bottle: 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: 5-30 litrepackaging material: HDPE.closure material is either: HDPE/LDPERevolver BAG: 1 litrepackaging material: EVAClosure : PP/Silicone/EVAdrum: 200 - 220 litrepackaging material: HDPEclosure material is either: PPIBC:900-1000 litrepackaging material: HDPE with steel frameclosure material is either: PP, HDPE

Table 9Use # 3 – Disinfection of surfaces with food and feed contact - spraying

Product type	PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: Bacteria including Mycobacterium tuberculosisCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: VirusesCommon name: -Development stage: -
Field(s) of use	IndoorDisinfection of clean non-porous surfaces in kitchens and food industry
Application method(s)	Method: SprayingDetailed description:Product will be sprayed directly on the surface.
Application rate(s) and frequency	Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.Dilution (%): -Number and timing of application:Disinfection when required according to SOP.
Category(ies) of users	IndustrialProfessional
Pack sizes and packaging material	Bottle: 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: 5-30 litrepackaging material: HDPE.closure material is either: HDPE/LDPERevolver BAG: 1 litrepackaging material: EVAClosure : PP/Silicone/EVAdrum: 200 - 220 litrepackaging material: HDPEclosure material is either: PPIBC: 900-1000 litrepackaging material: HDPE with steel frame closure material is either: PP, HDPE

Table 10Use # 4 – Disinfection of surfaces with food and feed contact - wiping

Product type	PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: Bacteria including Mycobacterium tuberculosisCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: VirusesCommon name: -Development stage: -
Field(s) of use	IndoorDisinfection of clean non-porous surfaces in kitchens and food industry
Application method(s)	Method: WipingDetailed description:Product will be sprayed or poured on the surface and wiped afterwards or the wipe will be wetted by spraying or pouring with the product and thereafter the product should be wiped on surface.
Application rate(s) and frequency	Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.Dilution (%): -Number and timing of application:Disinfection when required according to SOP.
Category(ies) of users	IndustrialProfessional
Pack sizes and packaging material	Bottle: 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: 5-30 litrepackaging material: HDPE.closure material is either: HDPE/LDPERevolver BAG: 1 litrepackaging material: EVAclosure material: PP/Silicone/EVAdrum: 200 - 220 litrepackaging material: HDPEclosure material is either: PPIBC: 900-1000 litrepackaging material: HDPE with steel frame closure material is either: PP, HDPE

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 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 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)	mikrozid® classic liquid		Market area: EU
	mikrozid® IPA liquid		Market area: EU
	Surface Disinfection liquid pure		Market area: EU
Authorisation number	EU-0023656-0003 1-3
Common name	IUPAC name	Function		CAS number	EC number	Content (%)
Propan-2-ol		Active Substance		67-63-0	200-661-7	63,1

META SPC 41.META SPC 4 ADMINISTRATIVE INFORMATION1.1.Meta SPC 4 identifier

Identifier

meta SPC 4 mikrozid wipes

1.2.Suffix to the authorisation number

Number

1-4

1.3.Product type(s)

Product type(s)

PT04 - Food and feed area (Disinfectants)PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

2.META SPC 4 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 4

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Propan-2-ol		Active Substance	67-63-0	200-661-7	63,1	63,1

2.2.Type(s) of formulation of the meta SPC 4

Formulation(s)

Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

Hazard statements

Highly flammable liquid and vapour.Causes serious eye irritation.May cause drowsiness or dizziness.Repeated exposure may cause skin dryness or cracking.

Precautionary statements

4.AUTHORISED USE(S) OF THE META SPC 44.1.Use description

Table 11Use # 1 – Disinfection of surfaces - wiping

Product type	PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: Bacteria including Mycobacterium tuberculosisCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: viruses (limited spectrum virucidal activity)Common name: -Development stage: -
Field(s) of use	IndoorDisinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas
Application method(s)	Method: WipingDetailed description:Product will be wiped directly on the surface.
Application rate(s) and frequency	Application Rate: Ready-to-use wipesDilution (%): -Number and timing of application:Disinfection when required according to SOP.
Category(ies) of users	IndustrialProfessional
Pack sizes and packaging material	Soft pack: 1-200 wipesPackaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPPPouch: 10-200 wipesPackaging material: LDPE/PETTube: 50-200 wipesPackaging material: HDPEclosure material is either PP, PE3385

Table 12Use # 2 – Disinfection of surfaces with food and feed contact - wiping

Product type	PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: Bacteria including Mycobacterium tuberculosisCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: VirusesCommon name: -Development stage: -
Field(s) of use	IndoorDisinfection of clean non-porous surfaces in kitchens and food industry
Application method(s)	Method: WipingDetailed description:Product will be wiped directly on the surface.
Application rate(s) and frequency	Application Rate: Ready-to-use wipesDilution (%): -Number and timing of application:Disinfection when required according to SOP.
Category(ies) of users	IndustrialProfessional
Pack sizes and packaging material	Soft pack: 1-200 wipesPackaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPPPouch: 10-200 wipesPackaging material: LDPE/PETTube: 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 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 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)	mikrozid® classic wipes		Market area: EU
	mikrozid® IPA wipes		Market area: EU
	surface disinfection wipes classic		Market area: EU
Authorisation number	EU-0023656-0004 1-4
Common name	IUPAC name	Function		CAS number	EC number	Content (%)
Propan-2-ol		Active Substance		67-63-0	200-661-7	63,1

META SPC 51.META SPC 5 ADMINISTRATIVE INFORMATION1.1.Meta SPC 5 identifier

Identifier

meta SPC 5 kodan wipes IPA pro

1.2.Suffix to the authorisation number

Number

1-5

1.3.Product type(s)

Product type(s)

PT04 - Food and feed area (Disinfectants)PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

2.META SPC 5 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 5

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Propan-2-ol		Active Substance	67-63-0	200-661-7	63,1	63,1

2.2.Type(s) of formulation of the meta SPC 5

Formulation(s)

Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

Hazard statements

Highly flammable liquid and vapour.Causes serious eye irritation.May cause drowsiness or dizziness.Repeated exposure may cause skin dryness or cracking.

Precautionary statements

4.AUTHORISED USE(S) OF THE META SPC 54.1.Use description

Table 13Use # 1 – Disinfection of surfaces - wiping

Product type	PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: Bacteria including Mycobacterium tuberculosisCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: viruses (limited spectrum virucidal activity)Common name: -Development stage: -
Field(s) of use	IndoorDisinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas
Application method(s)	Method: WipingDetailed description:Product will be wiped directly on the surface.
Application rate(s) and frequency	Application Rate: Ready-to-use wipesDilution (%): -Number and timing of application:-
Category(ies) of users	IndustrialProfessional
Pack sizes and packaging material	Soft pack: 1-200 wipesPackaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPPPouch: 10-200 wipesPackaging material: LDPE/PETTube: 50-200 wipesPackaging material: HDPEclosure material is either PP, PE3385

Table 14Use # 2 – Disinfection of surfaces with food and feed contact - wiping

Product type	PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: Bacteria including Mycobacterium tuberculosisCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: VirusesCommon name: -Development stage: -
Field(s) of use	IndoorDisinfection of clean non-porous surfaces in kitchens and food industry
Application method(s)	Method: WipingDetailed description:Product will be wiped directly on the surface.
Application rate(s) and frequency	Application Rate: Ready-to-use wipesDilution (%): -Number and timing of application:-
Category(ies) of users	IndustrialProfessional
Pack sizes and packaging material	Soft pack: 1-200 wipesPackaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPPPouch: 10-200 wipesPackaging material: LDPE/PETTube: 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 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 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)	kodan® wipes pure		Market area: EU
	schülke® classic wipes		Market area: EU
Authorisation number	EU-0023656-0005 1-5
Common name	IUPAC name	Function		CAS number	EC number	Content (%)
Propan-2-ol		Active Substance		67-63-0	200-661-7	63,1

META SPC 61.META SPC 6 ADMINISTRATIVE INFORMATION1.1.Meta SPC 6 identifier

Identifier

meta SPC 6 kodan wipes IPA

1.2.Suffix to the authorisation number

Number

1-6

1.3.Product type(s)

Product type(s)

PT04 - Food and feed area (Disinfectants)PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

2.META SPC 6 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 6

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Propan-2-ol		Active Substance	67-63-0	200-661-7	63,1	63,1

2.2.Type(s) of formulation of the meta SPC 6

Formulation(s)

Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6

Hazard statements

Highly flammable liquid and vapour.Causes serious eye irritation.May cause drowsiness or dizziness.Repeated exposure may cause skin dryness or cracking.

Precautionary statements

If medical advice is needed, have product container or label at hand.Keep out of reach of children.Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. - No smoking.Keep container tightly closed.Ground and bond container and receiving equipment.Use explosion-proof electrical/ventilating/lighting equipment.Use non-sparking tools.Take action to prevent static discharges.Avoid breathing vapours.Avoid breathing spray.Use only outdoors or in a well-ventilated area.IF INHALED:Remove person to fresh air and keep comfortable for breathing.IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.Call a POISON CENTER or doctor if you feel unwell.If eye irritation persists:Get medical advice.If eye irritation persists:Get medical attention.In case of fire:Use alcohol-resistant foam, carbon dioxide or water mist to extinguish.Store in a well-ventilated place.Keep cool.Store locked up.Dispose of contents to /container to an approved waste disposal plant.

4.AUTHORISED USE(S) OF THE META SPC 64.1.Use description

Table 15Use # 1 – Disinfection of surfaces - wiping

Product type	PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: Bacteria including Mycobacterium tuberculosisCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: viruses (limited spectrum virucidal activity)Common name: -Development stage: -
Field(s) of use	IndoorDisinfection of clean non-porous surfaces such as small work surfaces in medical and non-medical areas
Application method(s)	Method: WipingDetailed description:Product will be wiped directly on the surface.
Application rate(s) and frequency	Application Rate: Ready-to-use wipesDilution (%): -Number and timing of application:-
Category(ies) of users	IndustrialProfessionalGeneral public (non-professional)
Pack sizes and packaging material	Soft pack: 1-200 wipesPackaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPPPouch: 10-200 wipesPackaging material: LDPE/PETTube: 50-200 wipesPackaging material: HDPEclosure material is either PP, PE3385

Table 16Use # 2 – Disinfection of surfaces with food and feed contact - wiping

Product type	PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: Bacteria including Mycobacterium tuberculosisCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: VirusesCommon name: -Development stage: -
Field(s) of use	IndoorDisinfection of clean non-porous surfaces in kitchens and food industry
Application method(s)	Method: WipingDetailed description:Product will be wiped directly on the surface.
Application rate(s) and frequency	Application Rate: Ready-to-use wipesDilution (%): -Number and timing of application:-
Category(ies) of users	IndustrialProfessionalGeneral public (non-professional)
Pack sizes and packaging material	Soft pack: 1-200 wipesPackaging material: LDPE/Alu/PET; LDPE/PET; BOPP+CPPPouch: 10-200 wipesPackaging material: LDPE/PETTube: 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 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 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 Hygiene-Tücher		Market area: EU
	SOS Desinfizierende Feuchttücher		Market area: EU
	SOS Hygiene-Tücher		Market area: EU
	kodan® clean comfort wipes		Market area: EU
	schülke clean comfort wipes		Market area: EU
	Hygiene-Tücher		Market area: EU
	Desinfizierende Feuchttücher		Market area: EU
	Desinfektionstücher		Market area: EU
	clean comfort wipes		Market area: EU
	disinfecting wipes		Market area: EU
Authorisation number	EU-0023656-0006 1-6
Common name	IUPAC name	Function		CAS number	EC number	Content (%)
Propan-2-ol		Active Substance		67-63-0	200-661-7	63,1

META SPC 71.META SPC 7 ADMINISTRATIVE INFORMATION1.1.Meta SPC 7 identifier

Identifier

meta SPC 7 AntiLy SD

1.2.Suffix to the authorisation number

Number

1-7

1.3.Product type(s)

Product type(s)

PT04 - Food and feed area (Disinfectants)PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

2.META SPC 7 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 7

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Propan-2-ol		Active Substance	67-63-0	200-661-7	63,1	63,1

2.2.Type(s) of formulation of the meta SPC 7

Formulation(s)

Any other liquid (AL), ready-to-use

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7

Hazard statements

Highly flammable liquid and vapour.Causes serious eye irritation.May cause drowsiness or dizziness.Repeated exposure may cause skin dryness or cracking.

Precautionary statements

4.AUTHORISED USE(S) OF THE META SPC 74.1.Use description

Table 17Use # 1 – Disinfection of surfaces - spraying

Product type	PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: BacteriaCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -
Field(s) of use	IndoorDisinfection 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 frequency	Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.Dilution (%): -Number and timing of application:-
Category(ies) of users	IndustrialProfessional
Pack sizes and packaging material	Bottle: 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 18Use # 2 – Disinfection of surfaces - wiping

Product type	PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: BacteriaCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -
Field(s) of use	IndoorDisinfection 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 frequency	Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.Dilution (%): -Number and timing of application:-
Category(ies) of users	IndustrialProfessional
Pack sizes and packaging material	Bottle: 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 litrepackaging 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 19Use # 3 – Disinfection of surfaces with food and feed contact - spraying

Product type	PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: BacteriaCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: VirusesCommon name: -Development stage: -
Field(s) of use	IndoorDisinfection 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 frequency	Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.Dilution (%): -Number and timing of application:-
Category(ies) of users	IndustrialProfessional
Pack sizes and packaging material	Bottle: 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 20Use # 4 – Disinfection of surfaces with food and feed contact - wiping

Product type	PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: BacteriaCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: VirusesCommon name: -Development stage: -
Field(s) of use	IndoorDisinfection 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 frequency	Application Rate: Ready-to-use. Do not apply more than 25 ml/m2.Dilution (%): -Number and timing of application:-
Category(ies) of users	IndustrialProfessional
Pack sizes and packaging material	Bottle: 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 litrepackaging 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 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)	AntiLy 5		Market area: EU
Authorisation number	EU-0023656-0007 1-7
Common name	IUPAC name	Function		CAS number	EC number	Content (%)
Propan-2-ol		Active Substance		67-63-0	200-661-7	63,1

7.2.Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)	AntiLy 6		Market area: EU
Authorisation number	EU-0023656-0008 1-7
Common name	IUPAC name	Function		CAS number	EC number	Content (%)
Propan-2-ol		Active Substance		67-63-0	200-661-7	63,1

META SPC 81.META SPC 8 ADMINISTRATIVE INFORMATION1.1.Meta SPC 8 identifier

Identifier

meta SPC 8 AntiLy SD wipes

1.2.Suffix to the authorisation number

Number

1-8

1.3.Product type(s)

Product type(s)

PT04 - Food and feed area (Disinfectants)PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

2.META SPC 8 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 8

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	Min	Max
Propan-2-ol		Active Substance	67-63-0	200-661-7	63,1	63,1

2.2.Type(s) of formulation of the meta SPC 8

Formulation(s)

Any other liquid (AL), ready-to-use, wipes impregnated with disinfectant formulation

3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8

Hazard statements

Highly flammable liquid and vapour.Causes serious eye irritation.May cause drowsiness or dizziness.Repeated exposure may cause skin dryness or cracking.

Precautionary statements

4.AUTHORISED USE(S) OF THE META SPC 84.1.Use description

Table 21Use # 1 – Disinfection of surfaces - wiping

Product type	PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: BacteriaCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -
Field(s) of use	IndoorDisinfection 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 frequency	Application Rate: Ready-to-use wipesDilution (%): -Number and timing of application:-
Category(ies) of users	IndustrialProfessional
Pack sizes and packaging material	Can: 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 22Use # 2 – Disinfection of surfaces with food and feed contact - wiping

Product type	PT04 - Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: BacteriaCommon name: -Development stage: -Scientific name: YeastCommon name: -Development stage: -Scientific name: VirusesCommon name: -Development stage: -
Field(s) of use	IndoorDisinfection 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 frequency	Application Rate: Ready-to-use wipesDilution (%): -Number and timing of application:-
Category(ies) of users	IndustrialProfessional
Pack sizes and packaging material	Can: 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 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)	AntiLy 5 wipes
Authorisation number	EU-0023656-0009 1-8
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Propan-2-ol		Active Substance	67-63-0	200-661-7	63,1

7.2.Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)	AntiLy 6 wipes
Authorisation number	EU-0023656-0010 1-8
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Propan-2-ol		Active Substance	67-63-0	200-661-7	63,1