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Commission Implementing Regulation (EU) 2022/2252 of 11 November 2022 granting a Union authorisation for the biocidal product family Brenntag GmbH Propan-2-ol Product FamilyText with EEA relevance.

Den Europæiske UnionForordning2022

European Union

Commission Implementing Regulation (EU) 2022/2252 of 11 November 2022 granting a Union authorisation for the biocidal product family Brenntag GmbH Propan-2-ol Product Family (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products OJ L 167, 27.6.2012, p. 1. , and in particular the Article 44(5), first subparagraph, thereof, Whereas: (1) On 30 June 2016, Brenntag GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named Brenntag GmbH Propan-2-ol Product Family of product-types 1, 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Germany had agreed to evaluate the application. The application was recorded under case number BC-BL025673-43 in the Register for Biocidal Products. (2) Brenntag GmbH Propan-2-ol Product Family contains propan-2-ol as the active substance, which is included in the Union list of approved active substance referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 1, 2 and 4. (3) On 15 March 2021, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (the Agency). (4) On 4 November 2021, the Agency submitted to the Commission an opinion ECHA opinion of 7 October 2021 on the Union authorisation of Brenntag GmbH Propan-2-ol Product Family (ECHA/BPC/290/2021), https://echa.europa.eu/bpc-opinions-on-union-authorisation , including the draft summary of the biocidal product characteristics (SPC) of Brenntag GmbH Propan-2-ol Product Family and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. (5) The opinion concludes that Brenntag GmbH Propan-2-ol Product Family is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation. (6) On 22 November 2021, 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. (7) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for Brenntag GmbH Propan-2-ol Product Family. (8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on biocidal products, HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0027707-0000 is granted to Brenntag GmbH for the making available on the market and use of the biocidal product family Brenntag GmbH Propan-2-ol Product Family in accordance with the summary of the biocidal product characteristics set out in the Annex. The Union Authorisation is valid from 7 December 2022 to 30 November 2032.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 11 November 2022. For the Commission The President Ursula von der Leyen

Annex

ANNEX Summary of product characteristics for a biocidal product family Brenntag GmbH Propan-2-ol Product Family Product type 1 – Human hygiene (Disinfectants) Product type 4 – Food and feed area (Disinfectants) Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) Authorisation number: EU-0027707-0000 R4BP asset number: EU-0027707-0000 PART I FIRST INFORMATION LEVEL

  1. ADMINISTRATIVE INFORMATION 1.1. Family name NameBrenntag GmbH Propan-2-ol Product Family 1.2. Product type(s) Product type(s) PT01 – Human hygiene (Disinfectants) PT04 – Food and feed area (Disinfectants) PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) 1.3. Authorisation holder Name and address of the authorisation holderNameBrenntag GmbHAddressMesseallee 11, 45131 Essen GermanyAuthorisation numberEU-0027707-0000R4BP asset numberEU-0027707-0000Date of the authorisation7 December 2022Expiry date of the authorisation30 November 2032 1.4. Manufacturer(s) of the biocidal products Name of manufacturerKesla Pharma Wolfen GmbHAddress of manufacturerKesla-Str. 1, 06803 Bitterfeld GermanyLocation of manufacturing sitesKesla-Str. 1, 06803 Bitterfeld Germany Name of manufacturerDreve GmbHAddress of manufacturerMax-Planck-Str. 31, 59423 Unna GermanyLocation of manufacturing sitesKesla Pharma Wolfen GmbH, Kesla-Str. 1, 06803 Bitterfeld GermanyName of manufacturerBuzil-Werk Wagner GmbH & Co. KGAddress of manufacturerFraunhoferstr. 17, 87700 Memmingen GermanyLocation of manufacturing sitesFraunhoferstr. 17, 87700 Memmingen GermanyName of manufacturerWigol W. Stache GmbHAddress of manufacturerTextorstr. 2, 67547 Worms GermanyLocation of manufacturing sitesTextorstr. 2, 67547 Worms GermanyName of manufacturerKiiltoClean OyAddress of manufacturerTengströminkatu 6, FI-20630 Turku FinlandLocation of manufacturing sitesPL 157, FI-20101 Turku FinlandName of manufacturerWitty GmbH und Co. KGAddress of manufacturerHerrenrothstr. 12, 86424 Dinkelscherben GermanyLocation of manufacturing sitesHerrenrothstr. 12, 86424 Dinkelscherben GermanyName of manufacturerCarl Roth GmbH und Co. KGAddress of manufacturerAn der Mole 5, 76189 Karlsruhe GermanyLocation of manufacturing sitesAn der Mole 5, 76189 Karlsruhe GermanyName of manufacturerPro-cura Hy-med GmbHAddress of manufacturerStresemannstrasse 364, 22761 Hamburg GermanyLocation of manufacturing sitesA.F.P., Otto-Brenner-Str. 16, 21337 Lüneburg GermanyName of manufacturerPico-medical GmbHAddress of manufacturerFangdieckstr. 24, 22547 Hamburg GermanyLocation of manufacturing sitesA.F.P., Otto-Brenner-Str. 16, 21337 Lüneburg GermanyName of manufacturerAnti-Germ International GmbHAddress of manufacturerOberbrühlstr. 16, 87700 Memmingen GermanyLocation of manufacturing sitesOberbrühlstr. 16, 87700 Memmingen GermanyName of manufacturerLCI FLOWEYAddress of manufacturer2 ZAC Klengbusbierg, 7795 Bissen LuxembourgLocation of manufacturing sites2 ZAC Klengbusbierg, 7795 Bissen Luxembourg

Name of manufacturerHofmann & Sommer GmbH und Co. KGAddress of manufacturerLindenstr.11, 07426 Königsee-Rottenbach GermanyLocation of manufacturing sitesLindenstr.11, 07426 Königsee-Rottenbach GermanyName of manufacturerGirelli Alcool srlAddress of manufacturerVia Thomas Edison 5, 20080 Zibido San Giacomo (MI) ItalyLocation of manufacturing sitesVia Thomas Edison 5, 20080 Zibido San Giacomo (MI) ItalyName of manufacturerBrenntag S.p.A.Address of manufacturerVia Cusago 150/4, 20158 Milano (MI) ItalyLocation of manufacturing sitesVia Cusago 150/4, 20158 Milano (MI) ItalyName of manufacturerI.C.F. SrlAddress of manufacturerVia G.B. Benzoni 50, 26020 Palazzo Pignano (CR) ItalyLocation of manufacturing sitesVia G.B. Benzoni 50, 26020 Palazzo Pignano (CR) ItalyName of manufacturerBrenntag SAAddress of manufacturer90 Avenue du Progrès, 69 680 Chassieu FranceLocation of manufacturing sites90 Avenue du Progrès, 69 680 Chassieu FranceName of manufacturerBrenntag GmbHAddress of manufacturerStinnes-Platz 1, 45472 Muelheim a.d. Ruhr GermanyLocation of manufacturing sitesStinnes-Platz 1, 45472 Muelheim a.d. Ruhr GermanyName of manufacturerBCD Chemie GmbHAddress of manufacturerSchellerdamm 16, 21079 Hamburg GermanyLocation of manufacturing sitesSchellerdamm 16, 21079 Hamburg GermanyName of manufacturerHYDRACHIMAddress of manufacturerZ.A. ROUTE DE ST POIX, 35370 LE PERTRE FranceLocation of manufacturing sitesZ.A. du piquet, 35370 Etrelles FranceName of manufacturerLangguth Chemie GmbHAddress of manufacturerWandalenstrasse 6, 86343 Königsbrunn GermanyLocation of manufacturing sitesWandalenstrasse 6, 86343 Königsbrunn Germany Name of manufacturerBurgess Galvin & CoAddress of manufacturerJamestown Road, 11 Finglas, Dublin IrelandLocation of manufacturing sitesJamestown Road, 11 Finglas, Dublin IrelandName of manufacturerTristelAddress of manufacturerLynx Business Park, Fordham Road, CB8 7NY Snailwell, Cambridge United KingdomLocation of manufacturing sitesLynx Business Park, Fordham Road, CB8 7NY Snailwell, Cambridge United KingdomName of manufacturerBrenntag SchweizerhallAddress of manufacturerElsässerstrasse 231, 4056 Basel SwitzerlandLocation of manufacturing sitesElsässerstrasse 231, 4056 Basel SwitzerlandName of manufacturerORAPIAddress of manufacturer5 Allee des Cerdes, Pi de la Plaine de L’ain, 01150 Saint Vulbas FranceLocation of manufacturing sites5 Allee des Cerdes, Pi de la Plaine de L’ain, 01150 Saint Vulbas FranceName of manufacturerCopak S.A.Address of manufacturerZ.I. du Madrillet, rue de la Chênaie, 76800 Saint-Etienne-du-Rouvray FranceLocation of manufacturing sitesZ.I. du Madrillet, rue de la Chênaie, 76800 Saint-Etienne-du-Rouvray FranceName of manufacturerWater Technology LimitedAddress of manufacturerTOGHER INDUSTRIAL EST, T12KPF2 CORK, DUBLIN IrelandLocation of manufacturing sitesTOGHER INDUSTRIAL EST, T12KPF2 CORK, DUBLIN IrelandName of manufacturerAF International, Electrolube: Divisions of H K Wentworth LtdAddress of manufacturerAASHBY PARK, COALFIELD WAY, ASHBY DE LA ZOUCH, LE65 1JF LEICESTERSHIRE United KingdomLocation of manufacturing sitesAASHBY PARK, COALFIELD WAY, ASHBY DE LA ZOUCH, LE65 1JF LEICESTERSHIRE United KingdomName of manufacturerBello Mondo bvbaAddress of manufacturerHelststraat 150-159, 2630 Aartselaar BelgiumLocation of manufacturing sitesLaboratoria Smeets N.V., Fotografielaan 42, B-2610 Antwerpen-Wilrijk Belgium

Name of manufacturerCERICHEM BIOPHARM SRLAddress of manufacturerViale Einaudi snc (z.i.), 71042 Cerignola (FG) ItalyLocation of manufacturing sitesViale Einaudi snc (z.i.), 71042 Cerignola (FG) ItalyName of manufacturerOtto Fischar GmbH & Co. KGAddress of manufacturerKaiserstr. 221, 66133 Saarbruecken GermanyLocation of manufacturing sitesKaiserstr. 221, 66133 Saarbruecken GermanyName of manufacturerCaesar & Loretz GmbHAddress of manufacturerHerderstr. 31, 40721 Hilden GermanyLocation of manufacturing sitesHerderstr. 31, 40721 Hilden GermanyName of manufacturerKarl-Josef Kost Alkohole & Produkte aus Alkohol KGAddress of manufacturerRauentalshöhe 4, 56073 Koblenz GermanyLocation of manufacturing sitesRauentalshöhe 4, 56073 Koblenz Germany 1.5. Manufacturer(s) of the active substance(s) Active substancePropan-2-olName of manufacturerExxonMobilAddress of manufacturer4999 Scenic Highway, LA 70897 Baton Rouge, Louisiana United StatesLocation of manufacturing sites4999 Scenic Highway, LA 70897 Baton Rouge, Louisiana United StatesActive substancePropan-2-olName of manufacturerShell Nederland Raffinaderij B.V.Address of manufacturerVondelingenweg 601, Vodelingenenplaat, 3196 KK Rotterdam NetherlandsLocation of manufacturing sitesVondelingenweg 601, Vodelingenenplaat, 3196 KK Rotterdam NetherlandsActive substancePropan-2-olName of manufacturerINEOS Solvents Germany GmbHAddress of manufacturerRömerstrasse 733, 47443 Moers GermanyLocation of manufacturing sites Römerstrasse 733, 47443 Moers Germany Shamrockstraße 88, 44623 Herne Germany 2. PRODUCT FAMILY COMPOSITION AND FORMULATION 2.1. Qualitative and quantitative information on the composition of the family Common nameIUPAC nameFunctionCAS numberEC numberContent (%)MinMaxPropan-2-olActive Substance67-63-0200-661-762,770,0 2.2. Type(s) of formulation Formulation(s) Meta SPC 1: CL – Contact gel or Liquid Meta SPC 3: CL – Contact gel or Liquid Meta SPC 2: XX – Others: Ready-to-Use trigger spray PART II SECOND INFORMATION LEVEL – META SPC(S) META SPC 1

  1. META SPC 1 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 1 identifier IdentifierMeta SPC 1 1.2. Suffix to the authorisation number Number1-1 1.3. Product type(s) Product type(s)PT01 – Human hygiene (Disinfectants)
  2. META SPC 1 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 1 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)MinMaxPropan-2-olActive Substance67-63-0200-661-762,770,0 2.2. Type(s) of formulation of the meta SPC 1 Formulation(s)Meta SPC 1: CL – Contact gel or Liquid
  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 If medical advice is needed, have product container or label at hand. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking. Keep container tightly closed.

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/doctor if you feel unwell. If eye irritation persists:Get medical advice. If eye irritation persists:Get medical attention. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of contents to in accordance with local regulations. Dispose of container to in accordance with local regulations. 4. AUTHORISED USE(S) OF THE META SPC 1 4.1. Use description Table 1 Use # 1 – Use 1 – Contact Gel or Liquid – Hygienic handrub – Professional user Product typePT01 – Human hygiene (Disinfectants)Where relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria (incl. Mycobacteria), Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: Enveloped viruses Common name: - Development stage: - Field(s) of use Indoor For professional use only. For use in private, public, healthcare and industrial areas and in areas for professional activities. Application method(s) Method: Direct application to both hands, rubbing Detailed description:

Application rate(s) and frequency Application Rate: 3 ml applied to one hand and complete surface of both hands are moistened and rubbed for 60 seconds per application. Dilution (%): - Number and timing of application: Up to 25 disinfections per day, 5 day(s) per week Category(ies) of usersProfessionalPack sizes and packaging material Bottle HD-PE: 0,1L – 2,5L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP)) Can HD-PE: 5L – 60L; (Screw caps (PE/LDPE/HD-PE) or safety caps (HD-PE) Drum HD-PE: 200L; (Plastic plug with venting system (HD-PE) or Plastic plug for tap (HD-PE) or plastic tap (HD-PE) or seal caps (HD-PE)) IBC container HD-PE: 1000L; (Screw caps (HD-PE) 4.1.1. Use-specific instructions for use See general directions for use. 4.1.2. Use-specific risk mitigation measures See general directions for use. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 5. GENERAL DIRECTIONS FOR USE Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1. OF THE META SPC 1 5.1. Instructions for use 1) For professional use only. 2) Products must be shaken before use. 3) Only apply on dry and visibly clean hands.

For hand disinfection a ready-to-use gel or liquid (3 ml) is poured into the palms of one hand and the complete surface of both hands are moistened and rubbed for 60 seconds per application. 5.2. Risk mitigation measures 1) Avoid contact with eyes. 2) Keep out of reach of children and pets. 3) Use only in well-ventilated areas. 4) For refilling a funnel must be applied. 5) The following personal risk mitigation measure can be considered for refilling procedure unless it can be replaced by technical and/or organisational measures: The use of eye protection during refilling of the product is recommended. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment 1) IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. 2) IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. 5.4. Instructions for safe disposal of the product and its packaging 1) Product: Disposal together with normal waste is not allowed. Special disposal required according to local regulations. 2) Do not let product enter drains. 3) Contact waste disposal services. 4) Contaminated packaging: Empty contaminated packaging thoroughly. They can be recycled after thorough and proper cleaning. Packaging that cannot be cleaned are to be disposed of in the same manner as the product. 5) Do not burn, or use a cutting torch on, the empty drum. Risk of explosion. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage 1) Store in a well-ventilated place. 2) Keep cool. 3) Keep container tightly closed. 4) Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. 5) Shelf-life: 24 months 6. OTHER INFORMATION The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Wofasept AHAMarket area: EUOtovita® Professional HandgelMarket area: EUAuthorisation numberEU-0027707-0001 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-762,7 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Budenat® Protect Hand D807Market area: EUAuthorisation numberEU-0027707-0002 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-763,0 7.3. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Handsteril OGMarket area: EUDisinfection for Hands OGMarket area: EU2-Propanol 70 %Market area: EUIsopropylalkohol Königseer BiozidMarket area: EUIsogel Königseer Biozid PlusMarket area: EUIsogel Königseer BiozidMarket area: EUISO 70Market area: EUBrensolv K68Market area: EUIsopropanol 70 BiocideMarket area: EU

Isopropanol 70Market area: EUHand- und OberflächendesinfektionMarket area: EUAuthorisation numberEU-0027707-0003 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-770,0 7.4. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Handsteril OG blauMarket area: EUAuthorisation numberEU-0027707-0004 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-765,0 7.5. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)EasyseptMarket area: EUAuthorisation numberEU-0027707-0005 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-763,0 7.6. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Witty-Lavalin DMarket area: EUproCura Spray PURMarket area: EUOrlin Suprades HDMarket area: EUEseptMarket area: EUBio Tec Des HDMarket area: EU Authorisation numberEU-0027707-0006 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-763,1 7.7. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Curacid HD-septMarket area: EUAuthorisation numberEU-0027707-0007 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-762,8 7.8. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Esept GelMarket area: EUAuthorisation numberEU-0027707-0008 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-763,4 7.9. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Mano GermsMarket area: EUAuthorisation numberEU-0027707-0009 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-763,0 7.10. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Deogel ManiMarket area: EUDeovetMarket area: EUDeogel HandsMarket area: EUDeomedMarket area: EUDermigel profumatoMarket area: EUAuthorisation numberEU-0027707-0010 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-770,0 7.11. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)IsogelMarket area: EUVetgelMarket area: EUIcfgelMarket area: EUSkingelMarket area: EUSanigelMarket area: EUDermigelMarket area: EUGel mimaniMarket area: EUAuthorisation numberEU-0027707-0011 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-770,0 7.12. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Alcodet profumatoMarket area: EUAuthorisation numberEU-0027707-0012 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-770,0

7.13. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)HandsanMarket area: EUManisanMarket area: EUSanimedMarket area: EUAuthorisation numberEU-0027707-0013 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-770,0 7.14. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)ELIGELMarket area: EUAuthorisation numberEU-0027707-0014 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-770,0 7.15. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)ELIGEL PerfumMarket area: EUAuthorisation numberEU-0027707-0015 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-770,0 7.16. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Desmila VSIMarket area: EUmobilomed Skinsoft ExpertMarket area: EUSiMa CleanTecManoMarket area: EUFunny HygienikumMarket area: EU Authorisation numberEU-0027707-0016 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-762,8 7.17. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Desmila VSI CMarket area: EUAuthorisation numberEU-0027707-0017 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-763,0 7.18. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Desmila LSIMarket area: EUmobilomed Skinsoft ProfessionalMarket area: EUAuthorisation numberEU-0027707-0018 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-764,7 7.19. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Desmila LSI CMarket area: EUAuthorisation numberEU-0027707-0019 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-764,7 7.20. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Desmila LSI pureMarket area: EUAuthorisation numberEU-0027707-0020 1-1Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-764,7 META SPC 2

  1. META SPC 2 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 2 identifier IdentifierMeta SPC 2 1.2. Suffix to the authorisation number Number1-2 1.3. Product type(s) Product type(s) PT04 – Food and feed area (Disinfectants) PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  2. META SPC 2 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 2 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)MinMaxPropan-2-olActive Substance67-63-0200-661-762,870,0 2.2. Type(s) of formulation of the meta SPC 2

Formulation(s)Meta SPC 2: XX – Others: Ready-to-Use trigger spray 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 If medical advice is needed, have product container or label at hand. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking. Keep container tightly closed. 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/doctor if you feel unwell. If eye irritation persists:Get medical advice. If eye irritation persists:Get medical attention. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of contents to in accordance with local regulations. Dispose of container to in accordance with local regulations. 4. AUTHORISED USE(S) OF THE META SPC 2 4.1. Use description Table 2 Use # 1 – Use 1 – Liquid Spray – Small surface disinfection – Professional user Product typePT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)Where relevant, an exact description of the authorised useNot relevant.Target organism(s) (including development stage) Scientific name: Bacteria (incl. Mycobacteria), Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Field(s) of use Indoor Disinfection of small non-porous surfaces, materials, equipment and furniture in private, public, healthcare, industrial areas and in areas for professional activities. Application method(s) Method: Spraying Detailed description:

Application rate(s) and frequency Application Rate: For surface disinfection a ready-to-use spray solution (20 ml/m2) is applied on surfaces at room temperature. Dilution (%): - Number and timing of application: Application according to requirements, one application per use, 4 times per day. Small surface disinfection(other than healthcare): Bactericidal and yeasticidal: contact time at least 1 min In healthcare area: Bactericidal and yeasticidal: contact time at least 5 min Category(ies) of usersProfessionalPack sizes and packaging material Bottle HD-PE: 0,1L – 2,5L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP)) Can HD-PE: 5L – 60L; (Screw caps (PE/LDPE/HD-PE) or safety caps (HD-PE) Drum HD-PE: 200L; (Plastic plug with venting system (HD-PE) or Plastic plug for tap (HD-PE) or plastic tap (HD-PE) or seal caps (HD-PE)) IBC container HD-PE: 1000L; (Screw caps (HD-PE) 4.1.1. Use-specific instructions for use 1) Apply the ready-to-use product to the surface by spraying. Make sure to wet surfaces completely and wait for 1 minute (general surface disinfection) or 5 minutes (surfaces in healthcare area)

For use at room temperature. 3) Application according to requirements, one application per use, 4 times per day. 4.1.2. Use-specific risk mitigation measures The following personal risk mitigation measure can be considered for refilling procedure unless it can be replaced by technical and/or organisational measures: The use of eye protection during refilling of the product is recommended. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 4.2. Use description Table 3 Use # 2 – Use 2 – Liquid Spray – Disinfection for small food contact surfaces – Professional user Product typePT04 – Food and feed area (Disinfectants)Where relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Field(s) of use Indoor Disinfection of small non-porous surfaces in food sector or food processing industries (including breweries, dairy industry and meat industry). Application method(s) Method: Spraying Detailed description:

Application rate(s) and frequency Application Rate: For surface disinfection a ready-to-use spray solution (20 ml/m2) is applied on surfaces at room temperature. Dilution (%): - Number and timing of application: Application according to requirements, one application per use, 4 times per day. Small surface disinfection: Bactericidal and yeasticidal: contact time at least 1 min In Breweries/meat industry: Bactericidal and yeasticidal: contact time at least 5 min In dairy industry: Bactericidal and yeasticidal: contact time at least 15 min Category(ies) of usersProfessionalPack sizes and packaging material Bottle HD-PE: 0,1L – 2,5L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP)) Can HD-PE: 5L – 60L; (Screw caps (PE/LDPE/HD-PE) or safety caps (HD-PE) Drum HD-PE: 200L; (Plastic plug with venting system (HD-PE) or Plastic plug for tap (HD-PE) or plastic tap (HD-PE) or seal caps (HD-PE)) IBC container HD-PE: 1000L;(Screw caps (HD-PE) 4.2.1. Use-specific instructions for use 1) Apply the ready-to-use product to the surface by spraying. Make sure to wet surfaces completely and wait for at least 1 min (general surface disinfection), 5 min (surface disinfection in breweries or meat industry) or at least 15 min (surface disinfection in dairy industry). 2) For use at room temperature. 3) Application according to requirements, one application per use, 4 times per day. 4.2.2. Use-specific risk mitigation measures

The following personal risk mitigation measure can be considered for disinfection of food processing machinery and refilling procedure unless it can be replaced by technical and/or organisational measures: The use of eye protection during handling of the product is recommended. 4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use. 4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 5. GENERAL DIRECTIONS FOR USE Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2. OF THE META SPC 2 5.1. Instructions for use 1) Products must be shaken before use. 2) Do not apply more than 20 mL/m2. 3) Used wipes must be disposed in a closed container. 5.2. Risk mitigation measures 1) Avoid contact with eyes. 2) For refilling a funnel must be applied. 3) The product must only be applied for disinfection of small surfaces. 4) Keep out of reach of children and pets. 5) Use only in well-ventilated areas. 6) Keep children and pets away from rooms where disinfection is taking place. 7) Provide adequate ventilation before children and pets enter treated rooms. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment 1) IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. 2) IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. 5.4. Instructions for safe disposal of the product and its packaging 1) Product: Disposal together with normal waste is not allowed. Special disposal required according to local regulations. 2) Do not let product enter drains. 3) Contact waste disposal services. 4) Contaminated packaging: Empty contaminated packaging thoroughly. They can be recycled after thorough and proper cleaning. Packaging that cannot be cleaned are to be disposed of in the same manner as the product. 5) Do not burn, or use a cutting torch on, the empty drum. Risk of explosion. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage 1) Store in a well-ventilated place. 2) Keep cool. 3) Keep container tightly closed. 4) Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. 5) Shelf-life: 24 months 6. OTHER INFORMATION The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product. 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)proCura Spray PURMarket area: EUWitty-Express UltraMarket area: EUWitty-AQUA MEGAMarket area: EUAnti-Germ DES ALC-IPMarket area: EUBTS 6000Market area: EUBio Tec Des AXMarket area: EU Authorisation numberEU-0027707-0021 1-2Common 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)Isopropanol 70 BiocideMarket area: EUIsopropanol 70Market area: EUIsopropylalkohol Königseer BiozidMarket area: EUIsogel Königseer Biozid PlusMarket area: EUGoldMarket area: EUFüllersteril PPPMarket area: EUIsopropylalkohol 70 % Gew.Market area: EUFast GermsMarket area: EUBACTINYL IPA 70 %Market area: EUSAFE CLEANER SRMarket area: EUIsopropylalkohol Königseer Flächen BiozidMarket area: EUIsonetMarket area: EUIsonet ALMarket area: EUSanificante AlcolicoMarket area: EUIsogermMarket area: EUIsogerm ALMarket area: EUIsonet PUMarket area: EUAlidetMarket area: EUSanocasaMarket area: EUFrigosanoMarket area: EUHygien FoodMarket area: EUMedicalsanMarket area: EUAlcohol SanitizedMarket area: EUAlkosanMarket area: EUBiofarmMarket area: EU AllkillMarket area: EUDETERQUAT PRO SRMarket area: EUGaltec Isoprop BactericideMarket area: EUAmphisol 70Market area: EUAISW 100Market area: EUSteril Spray PPPMarket area: EUHand- und OberflächendesinfektionMarket area: EUAuthorisation numberEU-0027707-0022 1-2Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-770,0 7.3. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Budenat® Rapid Effect D 446Market area: EUIPA 300Market area: EUEasydes IPAMarket area: EUSonetMarket area: EUSonet ForteMarket area: EUIsosan ForteMarket area: EUGermisanMarket area: EUSanivetMarket area: EUAlidet ForteMarket area: EUGermodetMarket area: EUIsocleanMarket area: EUAlcohol Sanitized StrongMarket area: EUAlkosan StrongMarket area: EUIsonet StrongMarket area: EUDesmila HSIMarket area: EUVetasept purMarket area: EUAuthorisation numberEU-0027707-0023 1-2 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-763,0 7.4. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Isopropanol/Wasser 65/35 %Market area: EUAuthorisation numberEU-0027707-0024 1-2Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-765,0 7.5. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Curacid Food RapidMarket area: EUDr Desi KüchendesinfektionMarket area: EUAuthorisation numberEU-0027707-0025 1-2Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-762,8 7.6. Trade name(s), authorisation number and specific composition of each individual product

Trade name(s)DeogermMarket area: EUDeosanMarket area: EUMedicaldeoMarket area: EUDeonetMarket area: EUDeofloorMarket area: EUSanocasa ProfumatoMarket area: EUAuthorisation numberEU-0027707-0026 1-2 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-763,0 7.7. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Desmila HSI CMarket area: EUVetasept LemonMarket area: EUAuthorisation numberEU-0027707-0027 1-2Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-763,0 7.8. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Desmila HSI DMarket area: EUVetasept FreshMarket area: EUAuthorisation numberEU-0027707-0028 1-2Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-763,0 7.9. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Desmila HSI PMarket area: EUVetasept PfirsichMarket area: EUAuthorisation numberEU-0027707-0029 1-2Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-763,0 7.10. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Desmila AFIMarket area: EUHygienic IMarket area: EUAuthorisation numberEU-0027707-0030 1-2Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-764,7 META SPC 3

  1. META SPC 3 ADMINISTRATIVE INFORMATION 1.1. Meta SPC 3 identifier IdentifierMeta SPC 3 1.2. Suffix to the authorisation number Number1-3 1.3. Product type(s) Product type(s)PT01 – Human hygiene (Disinfectants)
  2. META SPC 3 COMPOSITION 2.1. Qualitative and quantitative information on the composition of the meta SPC 3 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)MinMaxPropan-2-olActive Substance67-63-0200-661-762,770,0 2.2. Type(s) of formulation of the meta SPC 3 Formulation(s)Meta SPC 3: CL – Contact gel or Liquid
  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 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. Avoid breathing vapours. Avoid breathing spray. Use only outdoors or in a well-ventilated area. 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/doctor if you feel unwell. If eye irritation persists:Get medical advice. If eye irritation persists:Get medical attention. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of contents to in accordance with local regulations.

Dispose of container to in accordance with local regulations. 4. AUTHORISED USE(S) OF THE META SPC 3 4.1. Use description Table 4 Use # 1 – Use 1 – Contact Gel or Liquid – Hygienic handrub – Non-professional user Product typePT01 – Human hygiene (Disinfectants)Where relevant, an exact description of the authorised useNot relevantTarget organism(s) (including development stage) Scientific name: Bacteria (incl. Mycobacteria), Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: Enveloped viruses Common name: - Development stage: - Field(s) of use Indoor For use in private and public areas. Application method(s) Method: Direct application to both hands, rubbing Detailed description:

Application rate(s) and frequency Application Rate: 3 ml applied to one hand and complete surface of both hands are moistened and rubbed for 60 seconds per application. Dilution (%): - Number and timing of application: Up to 5 disinfections per day, 5 day(s) per week Category(ies) of usersGeneral public (non-professional)Pack sizes and packaging materialBottle HD-PE: 0,1L – 1,0L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP)) 4.1.1. Use-specific instructions for use See general directions for use. 4.1.2. Use-specific risk mitigation measures See general directions for use. 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment See general directions for use. 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging See general directions for use. 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage See general directions for use. 5. GENERAL DIRECTIONS FOR USE Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3. OF THE META SPC 3 5.1. Instructions for use 1) Comply with the instructions for use. 2) Products must be shaken before use. 3) Only apply on dry and visibly clean hands. 4) For hand disinfection a ready-to-use gel or liquid (3 ml) is poured into the palms of one hand and the complete surface of both hands are moistened and rubbed for 60 seconds per application. 5) The authorisation holder has to specify the typical application rate in a simple, easily understandable form on the label: Trigger spray: Apply 3 or 4 spray strokes (depending on the trigger spray cap) Pump spray: Apply 3 pump strokes Bottle: Visual observation 5.2. Risk mitigation measures 1) Avoid contact with eyes. 2) Use by children only under supervision of an adult. 3) Use only in well-ventilated areas. 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment 1) If medical advice is needed, have product container or label at hand.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing for five minutes. 3) Call a POISON CENTER or doctor if you feel unwell. 4) If eye irritation persists: Get medical advice/attention. 5) IF INHALED OR SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor. 5.4. Instructions for safe disposal of the product and its packaging 1) Product: Disposal together with normal waste is not allowed. Special disposal required according to local regulations. 2) Do not let product enter drains. 3) Contact waste disposal services. 4) Contaminated packaging: Empty contaminated packaging thoroughly. They can be recycled after thorough and proper cleaning. Packaging that cannot be cleaned are to be disposed of in the same manner as the product. 5) Do not burn, or use a cutting torch on, the empty drum. Risk of explosion. 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage 1) Store in a well-ventilated place. 2) Keep cool. 3) Keep container tightly closed. 4) Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. 5) Keep out of reach of children and pets. 6) Shelf-life: 24 months 6. OTHER INFORMATION

  1. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3 7.1. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Frend Hand Sanitiser GelMarket area: EUAuthorisation numberEU-0027707-0031 1-3 Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-765,3 7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Biogat H-DesMarket area: EUAuthorisation numberEU-0027707-0032 1-3Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-770,0 7.3. Trade name(s), authorisation number and specific composition of each individual product Trade name(s)Neo-AmiseptMarket area: EUAuthorisation numberEU-0027707-0033 1-3Common nameIUPAC nameFunctionCAS numberEC numberContent (%)Propan-2-olActive Substance67-63-0200-661-763,0

Metadata

Type
Forordning
År
2022
Ikrafttrædelsesdato
1. januar 1970