Commission Implementing Regulation (EU) 2022/2127 of 4 November 2022 granting a Union authorisation for the biocidal product family ‘Ecolab UA BPF 1-Propanol’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
Corrected by
  • Corrigendum to Commission Implementing Regulation (EU) 2022/2127 of 4 November 2022 granting a Union authorisation for the biocidal product family Ecolab UA BPF 1-Propanol in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council, 32022R2127R(01), November 16, 2022
Commission Implementing Regulation (EU) 2022/2127of 4 November 2022granting a Union authorisation for the biocidal product family Ecolab UA BPF 1-Propanol in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council(Text with EEA relevance)
Article 1A Union authorisation with authorisation number EU-0028430-0000 is granted to Ecolab Deutschland GmbH for the making available on the market and use of the biocidal product family "Ecolab UA BPF 1-Propanol" in accordance with the summary of the biocidal product characteristics set out in the Annex.The Union authorisation is valid from 27 November 2022 to 31 October 2032.
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.ANNEXSummary of product characteristics for a biocidal product familyEcolab UA BPF 1-PropanolProduct type 1 – Human hygiene (Disinfectants)Authorisation number: EU-0028430-0000R4BP asset number: EU-0028430-0000PART IFIRST INFORMATION LEVEL1.ADMINISTRATIVE INFORMATION1.1.Family name
NameEcolab UA BPF 1-Propanol
1.2.Product type(s)
Product type(s)PT01 – Human hygiene (Disinfectants)
1.3.Authorisation holder
Name and address of the authorisation holderNameEcolab Deutschland GmbH
AddressEcolab Allee 1, 40789 Monheim am Rhein Germany
Authorisation numberEU-0028430-0000
R4BP asset numberEU-0028430-0000
Date of the authorisation27 November 2022
Expiry date of the authorisation31 October 2032
1.4.Manufacturer(s) of the biocidal products
Name of manufacturerEcolab Europe GmbH
Address of manufacturerRichtistrasse 7, 8304 Walliselen Switzerland
Location of manufacturing sitesRichtistrasse 7, 8304 Walliselen SwitzerlandAFP GmbH, Otto-Brenner-Straße 16, 21337 Lüneburg GermanyAcideka S.A., Edificio Feria. Capuchinos de Basurto 6. 4a planta, 48013 Bilbao SpainAdiego, Adiego Ctra De Valencia KM 5, 900, 50410 Cuarte de Huerva Zaragoza SpainAllied Products, Allied Hygiene Unit 11, Belvedere Industrial Estate, Fishers Way, Belvedere, Kent, DA17 6BS Belvedere United KingdomArkema GmbH, Morschheimer Straße 19, D-67292 Krichbeimbolanden GermanyAzelis Denmark, Lundtoftegårdsvej 95, 2800 Kgs Lyngby DenmarkBelinka-Ljublijana, Belinka Zasavska Cesta, 95 1001 Ljubljana SloveniaRadio street 24 Bld 1, 105005 Moscow Russian FederationBio Productions Ltd inc. Starpro, 72 Victoria Road Victoria Industrial Estate, West Sussex, RH15 9LH Burgess Hill United KingdomBioxal SA, Route des Varennes – Secteur A, BP 30072 71103 Cedex FranceBores Srl, Via Pioppa 179, 44030 Pontegradella (FE) ItalyBrenntag Ardennes, Route de Tournes, CD n 2, 08090 Cliron FranceBrenntag CEE – Guntramsdorf, Blending Bahnstr. 13 A, 2353 Guntramsdorf AustriaBrenntag GmbH, Humboldtring 15, 45472 Mülheim GermanyBrenntag Kaiserslautern, Merkurstr. 47, 67663 Kaiserslautern GermanyBrenntag Nordic – Haslev, Høsten Teglværksvej 47, 4690 Haslev DenmarkBrenntag Nordic – Vejle, Strandgade 35, 7100 Vejle DenmarkBrenntag Normandy, 12 Sente des Jumelles, BP 11 76710 Montville FranceBrenntag PL-Zgierz, ul. Kwasowa 5, 95-100 Zgierz PolandBrenntag Quimica, Calle Gutemberg no 22, Poligono Industrial El Lomo, 28906 Getafe Madrid SpainBrenntag Schweizerhall, Elsaesserstr. 231, CH-4056 Basel Schweiz SwitzerlandBrenntag SRL, Str. Gării nr 1, 077040 Chiaina, Ilfov RomaniaBudich International GmbH, Dieselstraße 10, 32120 Hiddenhause GermanyCaldic Deutschland Chemie B.V, Karlshof 10, D 40231 Düsseldorf GermanyThe Carbon Group„ P43 R772, County Cork Ringaskiddy IrelandColep Bad Schmiedeberg, Kemberger Str. 3, 06905 Bad Schmiedeberg GermanyComercial Farmaceutica Castel LANA S.A., "Cofarcas" Condado de Trevino 46 P.I Villalonquejar, 09080 Burgos SpainComercial Godo, França 13, 08700 Igaulada Barcelona SpainCourtois Sarl, ZA Sous Le Beer, Route de Pacy, 27730 Bueil FranceDAN-MOR (Dr Wipe) Natural products and Chemicals Ltd, Or Akiva Industrial Zone, Hailian street 29, 30600 Akiva IsraelDenteck BV, Heliumstraat 8, 2718 SL Zoetermeer NetherlandsDonauchem Kft (Hungary), Bányalég utca 37-43, H-1225 Budapest HungaryDetergents Burguera S.L, Joan Ballester 50, 07630 Campos (Illes Baleares) SpainChampion Technologies Ltd, Minto Avenue, Altens Industrial Estate, AB12 3JZ Aberdeen United KingdomECL Biebesheim, Justus-von-Liebig-Straße 11, 64584 Biebesheim am Rhein GermanyECL Chalons, Avenue Du General Patton, 51000 Chalons en Champagne FranceECL Cisterna, Nalco italiana Manufacturing Srl. Via Ninfina II, 04012 Cisterna di Latina ItalyChampion Technologies Ltd Fawley, Fawley Cadland Road Hythe, Hampshire, SO45 3NP Southampton United KingdomEcolab Leeds, Lotherton Way, Garforth, LS25 2JY Leeds United KingdomECL Mandra, 25TH KM Old National Road of Athens To Thiva, 19600 Mandra GreeceECL Maribor, Vajngerlova Ulica 4, 2000 Maribor SloveniaECL Microtek B.V., Gesinkkampstraat 19, 7051 HR Varsseveld NetherlandsECL Microtek Mosta, Sorbonne Centre F20 Mosta Technopark, Mst 3000 Mosta MaltaECL Microtek Zutphen, Hekkehorst 24, 7027 BN Zutphen NetherlandsEcolab Ltd (IE) and Ecolab Manufacturing IE Ltd (IE), Forest Park, Zone C Mullingar Ind. Estate N91, Co. Westmeath Mullingar IrelandECL Niewegein, Brugwal 11A, 3432 NZ Nieuwegein NetherlandsECL Rovigo Esoform, Esoform SRL Laboratorio Chimico Farmaceutico Viale del Lavoro 10, 45100 Rovigo ItalyECL Rozzano, Via A. Grandi, 20089 Milan ItalyECL Tessenderlo, Havenlaan 4, Ravenshout 4210, B-3980 Tessenderlo BelgiumECL Weavergate/Ecolab Ltd (UK)/Ecolab Manufacturing UK Ltd (UK), Winnington Avenue, CW8 3AA Northwich United KingdomEcolab LTD Baglan/Swindon, Plot 7a Baglan Energy Park, Baglan, SA11 2HZ Port Talbot United KingdomFerdinand Eiermacher GmbH & Co. KG, Westring 24, 48356 Nordwalde GermanyF.E.L.T., B.P 64 10 Rue du Vertuquet, 59531 Neuville En Ferrain FranceGallows Green Services Ltd, Cod Beck Mill Industrial Estate Dalton Lane, YO7 3HR Thirsk United KingdomGerdisa German Rodriguez Drogas IND., Gerdisa Poligono Industrial Miralcampo C.Pintura n.-4, parc.37, 19200 Azuqueca de Henares Guadalajara SpainGirasol Natural Products BV, De Veldoven 12-14, 3342 GR Hendrik-Ido-Ambacht NetherlandsHenkel Engels, 48 Pr. Stroitelei, 413116 Saratov Russian FederationIMECO GmbH & Co. KG, Boschstraße 5, D-63768 Hösbach GermanyInnovate GmbH, Am Hohen Stein 11, 06618 Naumberg GermanyInterfill LCC-Tosno, 187000 Moskovskoye shosse 1, 187000 Leningradskaya oblast Russian FederationJodel, Jodel Zona Industrial 2050, 2050 Aveiras de Cima PortugalKleimann GmbH, Am Trieb 13, 72820 Sonnenbühl GermanyKompak Nederland BV, 433651 Bavel 0031-161 Bavel NetherlandsLa Antigua Lavandera S.L., Ctra. Antigua Sevilla-Alcalá Km.1,5 (SE-410 Apartado de Correos 58, 41500 Alcala De Guadaira Sevilla SpainLaboratoires Anios, Pavé du moulin, 59260 Lille-Hellemmes FranceLaboratoires Anios, 3330 Rue de Lille, 59262 Sainghin-en-Mélantois FranceLaboratoires Prodene Klint, Site de Mitry-Mory 2, Rue Denis Papin ZI Mitry-Compans, 77290 Mitry Mory FranceLichtenheldt GmbH, Lichtenheldt Industriestraße 7-9, 23812 Wahlstedt GermanyLonza GmbH, Morianstr.32, 42103 Wuppertal GermanyMultifill BV, Constructieweg 25-A, 3641 SB Mijdrecht NetherlandsNALCO Finland Manufacturing Oy (Tesjoki), Kivikummuntie 1, 07955 Tesjoki FinlandNALCO Celra, Celra C/Tramuntana s/n Poligona Industrial, 17460 Celra SpainNOPA Nordisk Parfumerivare, Hvedevej 2-22, DK-8900 Randers DenmarkNuova Farmec Srl, Via Flemming 7, 37026 Settimo di Pescantina (VR) Verona ItalyPal International Ltd, Sandhurst Street, LE17 4JA Leicester United KingdomPlanol GmbH, Maybachstr. 17, 63456 Hanau GermanyPlum A/S, Frederik Plums Vej 2, DK 5610 Assens DenmarkProductos La Corberana S.L., Ctra Corbera Polinyá, s/no 4, 46612 Valencia SpainThe Proton Group Ltd, Ripley Drive, Normanton Industrial Estate, WF6 1QT Wakefield United KingdomQuimicas Morales S.L., Misiones, 11 Urb. El Sebadal, 05005 Las Palmas de Gran Canaria SpainRNM Productos Quimicos, Lda Rua da Fabrica 123, Segade, 4765-080 Carreira Vila Nova de Famalicao PortugalRP Adam Ltd (Arpal Group), North Riverside Business Park, Riverside Road„ TD7 5DU Selkirk United KingdomRoquette & Barentz, Roquette Freres, Route De La Gorgue, F-62136 Lestrem FranceRutpen Ltd, Membury Airfield, Lambourn, RG16 7TJ Membury United KingdomSimagec, Z.I. de Rousset/Peynier, 54 Avenue de la Plaine„ 13790 Rousset FranceSolimix, Montseny 17-19 Pol. Ind. Sant Pere, Molanta, 08799 Olerdola Barcelona SpainStaub & Co. – Silbermann GmbH, Industriestraße 3, D-86456 Gablingen GermanyStockmeier Chemie, Eilenburg GmbH & Co. Kg, Gustav-Adolf-Ring 5, 04838 Ellenburg GermanySynerlogic BV (IN2FOOD), L.J. Costerstraat 5, 6827 Arnhem NetherlandsTechtex (Technical Textile Services Ltd), Units 7 & 8, Rhodes Business Park Silburn Way, Middleton, M24 4NE Manchester United KingdomUnivar Ltd, Argyle House, Epsom Avenue, SK9 3RN Wilmslow United KingdomUnivar SPA, Via Caldera 21, 20-153 Milano ItalyVan Dam Bodegraven B.V, Postbus 48 NL, 2410 AA Bodegraven NetherlandsMcBride, Calle Ramón Esteve, 0 S/N (Pol L’Illa)„ 08650 Botjosa (la) Barcelona SpainExtruplast, Avenue de la Repentie, 1700 La Rochelle1 FranceBrenntag Hungary Kft, Bányalég u. 45, 1225 Budapest HungaryDR. Becher GmbH, Vor den Specken 3„ 30926 Seelze GermanyDanlind AS, Lægaardvej 90 – 94, DK-7500 Holstebro DenmarkFarmak Moravia a.s, Na Vlčinci 16„ 779 00 Oloumoc Czech RepublicHydrachem LTD, Gillmans Industrial Estate, Natts Lane, RH14 9EZ Billingshurst United KingdomJulius Hoesch GmbH, Birkesdorfer Str. 5, 52353 Düren GermanyMedentech LTD, Whitemill Industrial Estate, Wexford IrelandMKS GmbH & Co. KG, Am Ockenheimer Graben 43, 55411 Bingen am Rhein GermanyPDI, Aber Park, Aber Road, CH6 5EX Flint United KingdomPeenwhite LTD, Midpoint 18 Business Park, Aston Way„ CW10 0HS Middlewich United KingdomJago Pro Sp.z.o.o., Szczakowska 35, 43-600 Jaworzno PolandWesso AG, Martin-Luther-Str. 10, 91217 Hersbruck GermanyCID Lines NV, Waterpoorstraat 2, 8900 Leper Belgium
1.5.Manufacturer(s) of the active substance(s)
Active substancePropan-1-ol
Name of manufacturerBASF SE
Address of manufacturerCarl-Bosch-Str. 38, 67056 Ludwigshafen Germany
Location of manufacturing sitesCarl-Bosch-Str. 38, 67056 Ludwigshafen Germany
Active substancePropan-1-ol
Name of manufacturerOQ Corporation
Address of manufacturer2001 FM 3057, TX 77414 Bay City United States
Location of manufacturing sites2001 FM 3057, TX 77414 Bay City United States
2.PRODUCT FAMILY COMPOSITION AND FORMULATION2.1.Qualitative and quantitative information on the composition of the family
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Propan-1-olActive Substance71-23-8200-746-970,3575,38
2.2.Type(s) of formulation
Formulation(s)AL – Any other liquid
PART IISECOND INFORMATION LEVEL – META SPC(S)META SPC 11.META SPC 1 ADMINISTRATIVE INFORMATION1.1.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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 1
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Propan-1-olActive Substance71-23-8200-746-970,3575,38
2.2.Type(s) of formulation of the meta SPC 1
Formulation(s)AL – Any other liquid
3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
Hazard statementsFlammable liquid and vapour.Causes serious eye damage.May cause drowsiness or dizziness.Repeated exposure may cause skin dryness or cracking.
Precautionary statementsKeep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.Wear face protection.Wear eye protection.IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.Immediately call a POISON CENTER/doctor.Avoid breathing vapours.Call a POISONCENTRE/doctor if you feel unwell.
4.AUTHORISED USE(S) OF THE META SPC 14.1.Use description
Table 1.Use # 1 – Hand disinfection
Product typePT01 – Human hygiene (Disinfectants)
Where relevant, an exact description of the authorised useHygienic hand rub
Target organism(s) (including development stage)Scientific name: BacteriaCommon name: BacteriaDevelopment stage:Scientific name: Tuberculosis bacilliCommon name: Tuberculosis bacilliDevelopment stage:Scientific name: YeastsCommon name: YeastsDevelopment stage:Scientific name: Enveloped virusesCommon name: Enveloped virusesDevelopment stage:Scientific name: Viruses (limited spectrum virucidal activity)Common name: Viruses (limited spectrum virucidal activity)Development stage:
Field(s) of useIndoorIndoorHand disinfectionFood processing areas (industry, institutional and hospital kitchen areas (no contact with patients))Hygienic hand rub, on visibly clean hands
Application method(s)Method: Manual or automatic pumpDetailed description:Manual (elbow lever or touchless) Automatic (by pump)
Application rate(s) and frequencyApplication Rate: 3 mlDilution (%): Ready to useNumber and timing of application:10 times per day
Category(ies) of usersIndustrialProfessional
Pack sizes and packaging material100-20000 ml HEDP bottle, jerry can.
4.1.1.Use-specific instructions for useRefer to general measures (5.1)4.1.2.Use-specific risk mitigation measuresRefer to general measures (5.2))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 environmentRefer to general measures (5.3)4.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingRefer to general measures (5.4)4.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageRefer to general measures (5.5)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 useUse 1 – Hand disinfectionHand Disinfection for food processing areas:Apply 3 ml product on clean and dry hands for:30 seconds bacteria/yeast/tuberculosis bacilli/enveloped viruses60 seconds viruses (limited spectrum virucidal activity)Keep hands wet during whole contact time5.2.Risk mitigation measuresAvoid contact with eyes.If refilling is needed, gloves and eye protection should be used.In case of skin dryness, use appropriate skin care lotion.5.3.Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentIF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.IF SWALLOWED: Rinse mouth.If symptoms: Call 112/ambulance for medical assistance.If no symptoms: Call a POISON CENTRE or a doctor.Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.Environmental precautions: do not allow contact with soil, surface or ground water.5.4.Instructions for safe disposal of the product and its packagingProduct and product residues: Do not allow the product to enter drains, water courses or the soil. Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of the product in compliance with local regulations. Dispose of wastes in an approved waste disposal facilityPackaging: Bring empty containers to an approved waste handling site for recycling or disposal. Dispose of packaging only if completely empty and closed. Do not re-use empty containers. Dispose of in accordance with local, regional, national regulations.5.5.Conditions of storage and shelf-life of the product under normal conditions of storageKeep away from heat and sources of ignition. Keep in a cool, well-ventilated place. Keep away from oxidizing agents. Keep out of reach of children. Keep container tightly closed. Store in suitable labelled containers. Store between 0 °C to 25 °C.Shelf life: 4 years6.OTHER INFORMATION7.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)Skinman SensitiveMarket area: EU
P3-Manodes LIMarket area: EU
Epicare DESMarket area: EU
Manodes LIMarket area: EU
Authorisation numberEU-0028430-0001 1-1
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Propan-1-olActive Substance71-23-8200-746-970,35
Article 1A Union authorisation with authorisation number EU-0028430-0000 is granted to Ecolab Deutschland GmbH for the making available on the market and use of the biocidal product family "Ecolab UA BPF 1-Propanol" in accordance with the summary of the biocidal product characteristics set out in the Annex.The Union authorisation is valid from 27 November 2022 to 31 October 2032.
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.ANNEXSummary of product characteristics for a biocidal product familyEcolab UA BPF 1-PropanolProduct type 1 – Human hygiene (Disinfectants)Authorisation number: EU-0028430-0000R4BP asset number: EU-0028430-0000PART IFIRST INFORMATION LEVEL1.ADMINISTRATIVE INFORMATION1.1.Family name
NameEcolab UA BPF 1-Propanol
1.2.Product type(s)
Product type(s)PT01 – Human hygiene (Disinfectants)
1.3.Authorisation holder
Name and address of the authorisation holderNameEcolab Deutschland GmbH
AddressEcolab Allee 1, 40789 Monheim am Rhein Germany
Authorisation numberEU-0028430-0000
R4BP asset numberEU-0028430-0000
Date of the authorisation27 November 2022
Expiry date of the authorisation31 October 2032
1.4.Manufacturer(s) of the biocidal products
Name of manufacturerEcolab Europe GmbH
Address of manufacturerRichtistrasse 7, 8304 Walliselen Switzerland
Location of manufacturing sitesRichtistrasse 7, 8304 Walliselen SwitzerlandAFP GmbH, Otto-Brenner-Straße 16, 21337 Lüneburg GermanyAcideka S.A., Edificio Feria. Capuchinos de Basurto 6. 4a planta, 48013 Bilbao SpainAdiego, Adiego Ctra De Valencia KM 5, 900, 50410 Cuarte de Huerva Zaragoza SpainAllied Products, Allied Hygiene Unit 11, Belvedere Industrial Estate, Fishers Way, Belvedere, Kent, DA17 6BS Belvedere United KingdomArkema GmbH, Morschheimer Straße 19, D-67292 Krichbeimbolanden GermanyAzelis Denmark, Lundtoftegårdsvej 95, 2800 Kgs Lyngby DenmarkBelinka-Ljublijana, Belinka Zasavska Cesta, 95 1001 Ljubljana SloveniaRadio street 24 Bld 1, 105005 Moscow Russian FederationBio Productions Ltd inc. Starpro, 72 Victoria Road Victoria Industrial Estate, West Sussex, RH15 9LH Burgess Hill United KingdomBioxal SA, Route des Varennes – Secteur A, BP 30072 71103 Cedex FranceBores Srl, Via Pioppa 179, 44030 Pontegradella (FE) ItalyBrenntag Ardennes, Route de Tournes, CD n 2, 08090 Cliron FranceBrenntag CEE – Guntramsdorf, Blending Bahnstr. 13 A, 2353 Guntramsdorf AustriaBrenntag GmbH, Humboldtring 15, 45472 Mülheim GermanyBrenntag Kaiserslautern, Merkurstr. 47, 67663 Kaiserslautern GermanyBrenntag Nordic – Haslev, Høsten Teglværksvej 47, 4690 Haslev DenmarkBrenntag Nordic – Vejle, Strandgade 35, 7100 Vejle DenmarkBrenntag Normandy, 12 Sente des Jumelles, BP 11 76710 Montville FranceBrenntag PL-Zgierz, ul. Kwasowa 5, 95-100 Zgierz PolandBrenntag Quimica, Calle Gutemberg no 22, Poligono Industrial El Lomo, 28906 Getafe Madrid SpainBrenntag Schweizerhall, Elsaesserstr. 231, CH-4056 Basel Schweiz SwitzerlandBrenntag SRL, Str. Gării nr 1, 077040 Chiaina, Ilfov RomaniaBudich International GmbH, Dieselstraße 10, 32120 Hiddenhause GermanyCaldic Deutschland Chemie B.V, Karlshof 10, D 40231 Düsseldorf GermanyThe Carbon Group„ P43 R772, County Cork Ringaskiddy IrelandColep Bad Schmiedeberg, Kemberger Str. 3, 06905 Bad Schmiedeberg GermanyComercial Farmaceutica Castel LANA S.A., "Cofarcas" Condado de Trevino 46 P.I Villalonquejar, 09080 Burgos SpainComercial Godo, França 13, 08700 Igaulada Barcelona SpainCourtois Sarl, ZA Sous Le Beer, Route de Pacy, 27730 Bueil FranceDAN-MOR (Dr Wipe) Natural products and Chemicals Ltd, Or Akiva Industrial Zone, Hailian street 29, 30600 Akiva IsraelDenteck BV, Heliumstraat 8, 2718 SL Zoetermeer NetherlandsDonauchem Kft (Hungary), Bányalég utca 37-43, H-1225 Budapest HungaryDetergents Burguera S.L, Joan Ballester 50, 07630 Campos (Illes Baleares) SpainChampion Technologies Ltd, Minto Avenue, Altens Industrial Estate, AB12 3JZ Aberdeen United KingdomECL Biebesheim, Justus-von-Liebig-Straße 11, 64584 Biebesheim am Rhein GermanyECL Chalons, Avenue Du General Patton, 51000 Chalons en Champagne FranceECL Cisterna, Nalco italiana Manufacturing Srl. Via Ninfina II, 04012 Cisterna di Latina ItalyChampion Technologies Ltd Fawley, Fawley Cadland Road Hythe, Hampshire, SO45 3NP Southampton United KingdomEcolab Leeds, Lotherton Way, Garforth, LS25 2JY Leeds United KingdomECL Mandra, 25TH KM Old National Road of Athens To Thiva, 19600 Mandra GreeceECL Maribor, Vajngerlova Ulica 4, 2000 Maribor SloveniaECL Microtek B.V., Gesinkkampstraat 19, 7051 HR Varsseveld NetherlandsECL Microtek Mosta, Sorbonne Centre F20 Mosta Technopark, Mst 3000 Mosta MaltaECL Microtek Zutphen, Hekkehorst 24, 7027 BN Zutphen NetherlandsEcolab Ltd (IE) and Ecolab Manufacturing IE Ltd (IE), Forest Park, Zone C Mullingar Ind. Estate N91, Co. Westmeath Mullingar IrelandECL Niewegein, Brugwal 11A, 3432 NZ Nieuwegein NetherlandsECL Rovigo Esoform, Esoform SRL Laboratorio Chimico Farmaceutico Viale del Lavoro 10, 45100 Rovigo ItalyECL Rozzano, Via A. Grandi, 20089 Milan ItalyECL Tessenderlo, Havenlaan 4, Ravenshout 4210, B-3980 Tessenderlo BelgiumECL Weavergate/Ecolab Ltd (UK)/Ecolab Manufacturing UK Ltd (UK), Winnington Avenue, CW8 3AA Northwich United KingdomEcolab LTD Baglan/Swindon, Plot 7a Baglan Energy Park, Baglan, SA11 2HZ Port Talbot United KingdomFerdinand Eiermacher GmbH & Co. KG, Westring 24, 48356 Nordwalde GermanyF.E.L.T., B.P 64 10 Rue du Vertuquet, 59531 Neuville En Ferrain FranceGallows Green Services Ltd, Cod Beck Mill Industrial Estate Dalton Lane, YO7 3HR Thirsk United KingdomGerdisa German Rodriguez Drogas IND., Gerdisa Poligono Industrial Miralcampo C.Pintura n.-4, parc.37, 19200 Azuqueca de Henares Guadalajara SpainGirasol Natural Products BV, De Veldoven 12-14, 3342 GR Hendrik-Ido-Ambacht NetherlandsHenkel Engels, 48 Pr. Stroitelei, 413116 Saratov Russian FederationIMECO GmbH & Co. KG, Boschstraße 5, D-63768 Hösbach GermanyInnovate GmbH, Am Hohen Stein 11, 06618 Naumberg GermanyInterfill LCC-Tosno, 187000 Moskovskoye shosse 1, 187000 Leningradskaya oblast Russian FederationJodel, Jodel Zona Industrial 2050, 2050 Aveiras de Cima PortugalKleimann GmbH, Am Trieb 13, 72820 Sonnenbühl GermanyKompak Nederland BV, 433651 Bavel 0031-161 Bavel NetherlandsLa Antigua Lavandera S.L., Ctra. Antigua Sevilla-Alcalá Km.1,5 (SE-410 Apartado de Correos 58, 41500 Alcala De Guadaira Sevilla SpainLaboratoires Anios, Pavé du moulin, 59260 Lille-Hellemmes FranceLaboratoires Anios, 3330 Rue de Lille, 59262 Sainghin-en-Mélantois FranceLaboratoires Prodene Klint, Site de Mitry-Mory 2, Rue Denis Papin ZI Mitry-Compans, 77290 Mitry Mory FranceLichtenheldt GmbH, Lichtenheldt Industriestraße 7-9, 23812 Wahlstedt GermanyLonza GmbH, Morianstr.32, 42103 Wuppertal GermanyMultifill BV, Constructieweg 25-A, 3641 SB Mijdrecht NetherlandsNALCO Finland Manufacturing Oy (Tesjoki), Kivikummuntie 1, 07955 Tesjoki FinlandNALCO Celra, Celra C/Tramuntana s/n Poligona Industrial, 17460 Celra SpainNOPA Nordisk Parfumerivare, Hvedevej 2-22, DK-8900 Randers DenmarkNuova Farmec Srl, Via Flemming 7, 37026 Settimo di Pescantina (VR) Verona ItalyPal International Ltd, Sandhurst Street, LE17 4JA Leicester United KingdomPlanol GmbH, Maybachstr. 17, 63456 Hanau GermanyPlum A/S, Frederik Plums Vej 2, DK 5610 Assens DenmarkProductos La Corberana S.L., Ctra Corbera Polinyá, s/no 4, 46612 Valencia SpainThe Proton Group Ltd, Ripley Drive, Normanton Industrial Estate, WF6 1QT Wakefield United KingdomQuimicas Morales S.L., Misiones, 11 Urb. El Sebadal, 05005 Las Palmas de Gran Canaria SpainRNM Productos Quimicos, Lda Rua da Fabrica 123, Segade, 4765-080 Carreira Vila Nova de Famalicao PortugalRP Adam Ltd (Arpal Group), North Riverside Business Park, Riverside Road„ TD7 5DU Selkirk United KingdomRoquette & Barentz, Roquette Freres, Route De La Gorgue, F-62136 Lestrem FranceRutpen Ltd, Membury Airfield, Lambourn, RG16 7TJ Membury United KingdomSimagec, Z.I. de Rousset/Peynier, 54 Avenue de la Plaine„ 13790 Rousset FranceSolimix, Montseny 17-19 Pol. Ind. Sant Pere, Molanta, 08799 Olerdola Barcelona SpainStaub & Co. – Silbermann GmbH, Industriestraße 3, D-86456 Gablingen GermanyStockmeier Chemie, Eilenburg GmbH & Co. Kg, Gustav-Adolf-Ring 5, 04838 Ellenburg GermanySynerlogic BV (IN2FOOD), L.J. Costerstraat 5, 6827 Arnhem NetherlandsTechtex (Technical Textile Services Ltd), Units 7 & 8, Rhodes Business Park Silburn Way, Middleton, M24 4NE Manchester United KingdomUnivar Ltd, Argyle House, Epsom Avenue, SK9 3RN Wilmslow United KingdomUnivar SPA, Via Caldera 21, 20-153 Milano ItalyVan Dam Bodegraven B.V, Postbus 48 NL, 2410 AA Bodegraven NetherlandsMcBride, Calle Ramón Esteve, 0 S/N (Pol L’Illa)„ 08650 Botjosa (la) Barcelona SpainExtruplast, Avenue de la Repentie, 1700 La Rochelle1 FranceBrenntag Hungary Kft, Bányalég u. 45, 1225 Budapest HungaryDR. Becher GmbH, Vor den Specken 3„ 30926 Seelze GermanyDanlind AS, Lægaardvej 90 – 94, DK-7500 Holstebro DenmarkFarmak Moravia a.s, Na Vlčinci 16„ 779 00 Oloumoc Czech RepublicHydrachem LTD, Gillmans Industrial Estate, Natts Lane, RH14 9EZ Billingshurst United KingdomJulius Hoesch GmbH, Birkesdorfer Str. 5, 52353 Düren GermanyMedentech LTD, Whitemill Industrial Estate, Wexford IrelandMKS GmbH & Co. KG, Am Ockenheimer Graben 43, 55411 Bingen am Rhein GermanyPDI, Aber Park, Aber Road, CH6 5EX Flint United KingdomPeenwhite LTD, Midpoint 18 Business Park, Aston Way„ CW10 0HS Middlewich United KingdomJago Pro Sp.z.o.o., Szczakowska 35, 43-600 Jaworzno PolandWesso AG, Martin-Luther-Str. 10, 91217 Hersbruck GermanyCID Lines NV, Waterpoorstraat 2, 8900 Leper Belgium
1.5.Manufacturer(s) of the active substance(s)
Active substancePropan-1-ol
Name of manufacturerBASF SE
Address of manufacturerCarl-Bosch-Str. 38, 67056 Ludwigshafen Germany
Location of manufacturing sitesCarl-Bosch-Str. 38, 67056 Ludwigshafen Germany
Active substancePropan-1-ol
Name of manufacturerOQ Corporation
Address of manufacturer2001 FM 3057, TX 77414 Bay City United States
Location of manufacturing sites2001 FM 3057, TX 77414 Bay City United States
2.PRODUCT FAMILY COMPOSITION AND FORMULATION2.1.Qualitative and quantitative information on the composition of the family
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Propan-1-olActive Substance71-23-8200-746-970,3575,38
2.2.Type(s) of formulation
Formulation(s)AL – Any other liquid
PART IISECOND INFORMATION LEVEL – META SPC(S)META SPC 11.META SPC 1 ADMINISTRATIVE INFORMATION1.1.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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 1
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
MinMax
Propan-1-olActive Substance71-23-8200-746-970,3575,38
2.2.Type(s) of formulation of the meta SPC 1
Formulation(s)AL – Any other liquid
3.HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
Hazard statementsFlammable liquid and vapour.Causes serious eye damage.May cause drowsiness or dizziness.Repeated exposure may cause skin dryness or cracking.
Precautionary statementsKeep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.Wear face protection.Wear eye protection.IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.Immediately call a POISON CENTER/doctor.Avoid breathing vapours.Call a POISONCENTRE/doctor if you feel unwell.
4.AUTHORISED USE(S) OF THE META SPC 14.1.Use description
Table 1.Use # 1 – Hand disinfection
Product typePT01 – Human hygiene (Disinfectants)
Where relevant, an exact description of the authorised useHygienic hand rub
Target organism(s) (including development stage)Scientific name: BacteriaCommon name: BacteriaDevelopment stage:Scientific name: Tuberculosis bacilliCommon name: Tuberculosis bacilliDevelopment stage:Scientific name: YeastsCommon name: YeastsDevelopment stage:Scientific name: Enveloped virusesCommon name: Enveloped virusesDevelopment stage:Scientific name: Viruses (limited spectrum virucidal activity)Common name: Viruses (limited spectrum virucidal activity)Development stage:
Field(s) of useIndoorIndoorHand disinfectionFood processing areas (industry, institutional and hospital kitchen areas (no contact with patients))Hygienic hand rub, on visibly clean hands
Application method(s)Method: Manual or automatic pumpDetailed description:Manual (elbow lever or touchless) Automatic (by pump)
Application rate(s) and frequencyApplication Rate: 3 mlDilution (%): Ready to useNumber and timing of application:10 times per day
Category(ies) of usersIndustrialProfessional
Pack sizes and packaging material100-20000 ml HEDP bottle, jerry can.
4.1.1.Use-specific instructions for useRefer to general measures (5.1)4.1.2.Use-specific risk mitigation measuresRefer to general measures (5.2))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 environmentRefer to general measures (5.3)4.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingRefer to general measures (5.4)4.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageRefer to general measures (5.5)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 useUse 1 – Hand disinfectionHand Disinfection for food processing areas:Apply 3 ml product on clean and dry hands for:30 seconds bacteria/yeast/tuberculosis bacilli/enveloped viruses60 seconds viruses (limited spectrum virucidal activity)Keep hands wet during whole contact time5.2.Risk mitigation measuresAvoid contact with eyes.If refilling is needed, gloves and eye protection should be used.In case of skin dryness, use appropriate skin care lotion.5.3.Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentIF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.IF SWALLOWED: Rinse mouth.If symptoms: Call 112/ambulance for medical assistance.If no symptoms: Call a POISON CENTRE or a doctor.Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.IF ON SKIN: If irritation occurs wash with water and seek medical advice. In cases of unintentional skin exposure: wash with water.IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.Environmental precautions: do not allow contact with soil, surface or ground water.5.4.Instructions for safe disposal of the product and its packagingProduct and product residues: Do not allow the product to enter drains, water courses or the soil. Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of the product in compliance with local regulations. Dispose of wastes in an approved waste disposal facilityPackaging: Bring empty containers to an approved waste handling site for recycling or disposal. Dispose of packaging only if completely empty and closed. Do not re-use empty containers. Dispose of in accordance with local, regional, national regulations.5.5.Conditions of storage and shelf-life of the product under normal conditions of storageKeep away from heat and sources of ignition. Keep in a cool, well-ventilated place. Keep away from oxidizing agents. Keep out of reach of children. Keep container tightly closed. Store in suitable labelled containers. Store between 0 °C to 25 °C.Shelf life: 4 years6.OTHER INFORMATION7.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)Skinman SensitiveMarket area: EU
P3-Manodes LIMarket area: EU
Epicare DESMarket area: EU
Manodes LIMarket area: EU
Authorisation numberEU-0028430-0001 1-1
Common nameIUPAC nameFunctionCAS numberEC numberContent (%)
Propan-1-olActive Substance71-23-8200-746-970,35