LegalizeCommission 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)
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.
ANNEX
Summary of product characteristics for a biocidal product family
Brenntag GmbH Propan-2-ol Product Family
Product type(s)
PT01: Human hygiene
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
Authorisation number EU-0027707-0000
R4BP asset number EU-0027707-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1. Family name
| Name | Brenntag GmbH Propan-2-ol Product Family |
1.2. Product type(s)
| Product type(s) | PT01: Human hygiene PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area |
1.3. Authorisation holder
| Name and address of the authorisation holder | Name | Brenntag GmbH |
| Name and address of the authorisation holder | Address | Messeallee 11 45131 Essen DE |
| Authorisation number | EU-0027707-0000 | |
| R4BP asset number | EU-0027707-0000 | |
| Date of the authorisation | 7.12.2022 | |
| Expiry date of the authorisation | 30.11.2032 |
1.4. Manufacturer(s) of the product
| Name of manufacturer | Kesla Pharma Wolfen GmbH |
| Address of manufacturer | Kesla-Str. 1 06803 Bitterfeld Germany |
| Location of manufacturing sites | Kesla Pharma Wolfen GmbH site 1 Kesla-Str. 1 06803 Bitterfeld Germany |
| --- | --- |
| Name of manufacturer | Buzil-Werk Wagner GmbH & Co. KG |
| Address of manufacturer | Fraunhoferstr. 17 87700 Memmingen Germany |
| Location of manufacturing sites | Buzil-Werk Wagner GmbH & Co. KG site 1 Fraunhoferstr. 17 87700 Memmingen Germany |
| --- | --- |
| Name of manufacturer | Wigol W. Stache GmbH |
| Address of manufacturer | Textorstr. 2 67547 Worms Germany |
| Location of manufacturing sites | Wigol W. Stache GmbH site 1 Textorstr. 2 67547 Worms Germany |
| --- | --- |
| Name of manufacturer | KiiltoClean Oy |
| Address of manufacturer | Tengströminkatu 6 FI-20630 Turku Finland |
| Location of manufacturing sites | KiiltoClean Oy site 1 PL 157 FI-20101 Turku Finland |
| --- | --- |
| Name of manufacturer | Witty GmbH und Co. KG |
| Address of manufacturer | Herrenrothstr. 12 86424 Dinkelscherben Germany |
| Location of manufacturing sites | Witty GmbH und Co. KG site 1 Herrenrothstr. 12 86424 Dinkelscherben Germany |
| --- | --- |
| Name of manufacturer | Carl Roth GmbH und Co. KG |
| Address of manufacturer | An der Mole 5 76189 Karlsruhe Germany |
| Location of manufacturing sites | Carl Roth GmbH und Co. KG site 1 An der Mole 5 76189 Karlsruhe Germany |
| --- | --- |
| Name of manufacturer | Anti-Germ International GmbH |
| Address of manufacturer | Oberbrühlstr. 16 87700 Memmingen Germany |
| Location of manufacturing sites | Anti-Germ International GmbH site 1 Oberbrühlstr. 16 87700 Memmingen Germany |
| --- | --- |
| Name of manufacturer | LCI FLOWEY |
| Address of manufacturer | 2 ZAC Klengbusbierg 7795 Bissen Luxembourg |
| Location of manufacturing sites | LCI FLOWEY site 1 2 ZAC Klengbusbierg 7795 Bissen Luxembourg |
| --- | --- |
| Name of manufacturer | Hofmann & Sommer GmbH und Co. KG |
| Address of manufacturer | Lindenstr.11 07426 Königsee-Rottenbach Germany |
| Location of manufacturing sites | Hofmann & Sommer GmbH und Co. KG site 1 Lindenstr.11 07426 Königsee-Rottenbach Germany |
| --- | --- |
| Name of manufacturer | Girelli Alcool srl |
| Address of manufacturer | Via Thomas Edison 5 20080 Zibido San Giacomo (MI) Italy |
| Location of manufacturing sites | Girelli Alcool srl site 1 Via Thomas Edison 5 20080 Zibido San Giacomo (MI) Italy |
| --- | --- |
| Name of manufacturer | Brenntag S.p.A. |
| Address of manufacturer | Via Cusago 150/4 20158 Milano (MI) Italy |
| Location of manufacturing sites | Brenntag S.p.A. site 1 Via Cusago 150/4 20158 Milano (MI) Italy |
| --- | --- |
| Name of manufacturer | Brenntag SA |
| Address of manufacturer | 90 Avenue du Progrès 69 680 Chassieu France |
| Location of manufacturing sites | Brenntag SA site 1 90 Avenue du Progrès 69 680 Chassieu France |
| --- | --- |
| Name of manufacturer | HYDRACHIM |
| Address of manufacturer | Z.A. ROUTE DE ST POIX 35370 LE PERTRE France |
| Location of manufacturing sites | HYDRACHIM site 1 Z.A. du piquet 35370 Etrelles France |
| --- | --- |
| Name of manufacturer | Langguth Chemie GmbH |
| Address of manufacturer | Wandalenstrasse 6 86343 Königsbrunn Germany |
| Location of manufacturing sites | Langguth Chemie GmbH site 1 Wandalenstrasse 6 86343 Königsbrunn Germany |
| --- | --- |
| Name of manufacturer | Burgess Galvin & Co |
| Address of manufacturer | Jamestown Road 11 Finglas, Dublin Ireland |
| Location of manufacturing sites | Burgess Galvin & Co site 1 Jamestown Road 11 Finglas, Dublin Ireland |
| --- | --- |
| Name of manufacturer | Brenntag Schweizerhall |
| Address of manufacturer | Elsässerstrasse 231 4056 Basel Switzerland |
| Location of manufacturing sites | Brenntag Schweizerhall site 1 Elsässerstrasse 231 4056 Basel Switzerland |
| --- | --- |
| Name of manufacturer | ORAPI |
| Address of manufacturer | 5 Allee des Cerdes, Pi de la Plaine de L’ain 01150 Saint Vulbas France |
| Location of manufacturing sites | ORAPI site 1 5 Allee des Cerdes, Pi de la Plaine de L’ain 01150 Saint Vulbas France |
| --- | --- |
| Name of manufacturer | Copak S.A. |
| Address of manufacturer | Z.I. du Madrillet, rue de la Chênaie 76800 Saint-Etienne-du-Rouvray France |
| Location of manufacturing sites | Copak S.A. site 1 Z.I. du Madrillet, rue de la Chênaie 76800 Saint-Etienne-du-Rouvray France |
| --- | --- |
| Name of manufacturer | Water Technology Limited |
| Address of manufacturer | TOGHER INDUSTRIAL EST T12KPF2 CORK, DUBLIN Ireland |
| Location of manufacturing sites | Water Technology Limited site 1 TOGHER INDUSTRIAL EST T12KPF2 CORK, DUBLIN Ireland |
| --- | --- |
| Name of manufacturer | Otto Fischar GmbH & Co. KG |
| Address of manufacturer | Kaiserstr. 221 66133 Saarbruecken Germany |
| Location of manufacturing sites | Otto Fischar GmbH & Co. KG site 1 Kaiserstr. 221 66133 Saarbruecken Germany |
| --- | --- |
| Name of manufacturer | Caesar & Loretz GmbH |
| Address of manufacturer | Herderstr. 31 40721 Hilden Germany |
| Location of manufacturing sites | Caesar & Loretz GmbH site 1 Herderstr. 31 40721 Hilden Germany |
| --- | --- |
| Name of manufacturer | Karl-Josef Kost Alkohole & Produkte aus Alkohol KG |
| Address of manufacturer | Rauentalshöhe 4 56073 Koblenz Germany |
| Location of manufacturing sites | Karl-Josef Kost Alkohole & Produkte aus Alkohol KG site 1 Rauentalshöhe 4 56073 Koblenz Germany |
| --- | --- |
| Name of manufacturer | Höfer Chemie GmbH |
| Address of manufacturer | Zur Fabrik 2 66271 Kleinblittersdorf Germany |
| Location of manufacturing sites | Höfer Chemie GmbH site 1 Zur Fabrik 2 66271 Kleinblittersdorf Germany |
| --- | --- |
| Name of manufacturer | HWR-CHEMIE GmbH |
| Address of manufacturer | Moosfeldstraße 7 82275 Emmering Germany |
| Location of manufacturing sites | HWR-CHEMIE GmbH site 1 Moosfeldstraße 7 82275 Emmering Germany |
| --- | --- |
| Name of manufacturer | Renosan Chemie Technik GmbH |
| Address of manufacturer | Schützenstraße 5 98527 Suhl Germany |
| Location of manufacturing sites | Renosan Chemie Technik GmbH site 1 Schützenstraße 5 98527 Suhl Germany |
| --- | --- |
| Name of manufacturer | Gruppo LGM Srl |
| Address of manufacturer | Via Pola 32 20096 Pioltello (MI) Italy |
| Location of manufacturing sites | Gruppo LGM Srl site 1 Via Pola 32 20096 Pioltello (MI) Italy |
| --- | --- |
| Name of manufacturer | Brenntag Nordic A/S |
| Address of manufacturer | Høsten Teglværksvej 47 4690 Haslev Denmark |
| Location of manufacturing sites | Brenntag Nordic A/S site 1 Høsten Teglværksvej 47 4690 Haslev Denmark |
| --- | --- |
| Name of manufacturer | Brenntag GmbH |
| Address of manufacturer | Am Nordseekai 22 73207 Plochingen Germany |
| Location of manufacturing sites | Brenntag GmbH Am Nordseekai 22 73207 Plochingen Germany |
| --- | --- |
| Name of manufacturer | Brenntag GmbH |
| Address of manufacturer | Am Röhrenwerk 46 47259 Duisburg Germany |
| Location of manufacturing sites | Brenntag GmbH Am Röhrenwerk 46 47259 Duisburg Germany |
| --- | --- |
| Name of manufacturer | Brenntag GmbH |
| Address of manufacturer | Hannoversche Strasse 40 21079 Hamburg Germany |
| Location of manufacturing sites | Brenntag GmbH Hannoversche Strasse 40 21079 Hamburg Germany |
| --- | --- |
| Name of manufacturer | Hypred SAS - Kersia Group |
| Address of manufacturer | 55 Boulevard Jules Verger, BP 10180 35803 Dinard Cedex France |
| Location of manufacturing sites | Hypred SAS - Kersia Group (Dinard site) 55 Boulevard Jules Verger, BP 10180 35803 Dinard Cedex France Hypred SAS - Kersia Group (Vaas site) Zone Industrielle Le Roineau 72500 Vaas France |
| --- | --- |
| Name of manufacturer | Medentech Ltd - Kersia Group |
| Address of manufacturer | Clonard Road Y35Y7WY Wexford Ireland |
| Location of manufacturing sites | Medentech Ltd - Kersia Group site 1 Clonard Road Y35Y7WY Wexford Ireland |
| --- | --- |
| Name of manufacturer | ACT Aerosol Chemie Technik GmbH |
| Address of manufacturer | Porschestrasse 7 73095 Albershausen Germany |
| Location of manufacturing sites | ACT Aerosol Chemie Technik GmbH site 1 Porschestrasse 7 73095 Albershausen Germany |
1.5. Manufacturer(s) of the active substance(s)
| Active substance | Propan-2-ol |
| Name of manufacturer | ExxonMobil |
| Address of manufacturer | 4999 Scenic Highway LA 70897 Baton Rouge, Louisiana United States (the) |
| Location of manufacturing sites | ExxonMobil site 1 4999 Scenic Highway LA 70897 Baton Rouge, Louisiana United States (the) |
| --- | --- |
| Active substance | Propan-2-ol |
| Name of manufacturer | Shell Nederland Raffinaderij B.V. |
| Address of manufacturer | Vondelingenweg 601, Vodelingenenplaat 3196 KK Rotterdam Netherlands (the) |
| Location of manufacturing sites | Shell Nederland Raffinaderij B.V. site 1 Vondelingenweg 601, Vodelingenenplaat 3196 KK Rotterdam Netherlands (the) |
| --- | --- |
| Active substance | Propan-2-ol |
| Name of manufacturer | INEOS Solvents Germany GmbH |
| Address of manufacturer | Römerstrasse 733 47443 Moers Germany |
| Location of manufacturing sites | INEOS Solvents Germany GmbH site 1 Römerstrasse 733 47443 Moers Germany INEOS Solvents Germany GmbH site 2 Shamrockstraße 88 44623 Herne Germany |
2. PRODUCT FAMILY COMPOSITION AND FORMULATION
2.1. Qualitative and quantitative information on the composition of the family
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| Propan-2-ol | Active substance | 67-63-0 | 200-661-7 | 62,7 - 70 % (w/w) |
2.2. Type(s) of formulation
| Formulation type(s) | Meta SPC 1: CL - Contact gel or Liquid Meta SPC 2: XX – Others: Ready-to-Use trigger spray Meta SPC 3: CL - Contact gel or Liquid |
PART II
SECOND INFORMATION LEVEL META SPC(S)
1. META SPC 1 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 1 identifier
| Identifier | Meta SPC: Meta SPC 1 |
1.2. Suffix to the authorisation number
| Number | 1-1 |
1.3. Product type(s)
| Product type(s) | PT01: Human hygiene |
2. META SPC 1 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 1
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| Propan-2-ol | Active substance | 67-63-0 | 200-661-7 | 62,7 - 70 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 1
| Formulation type(s) | Meta SPC 1: CL - Contact gel or Liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
| Hazard statements | H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. |
| Precautionary statements | P101: If medical advice is needed, have product container or label at hand. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P261: Avoid breathing vapours. P261: Avoid breathing spray. P271: Use only outdoors or in a well-ventilated area. P280: Wear eye protection. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER/ doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical advice. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local regulations. P501: Dispose of container in accordance with local regulations. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use 1 – Contact Gel or Liquid - Hygienic handrub - Professional user
| Product type | PT01: Human hygiene |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target 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 use 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. - Number and timing of application: Up to 25 disinfections per day, 5 day(s) per week |
| Category(ies) of users | professional |
| Pack 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 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.
- 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.
5.2. 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) | Trade name(s) | Trade name(s) | Wofasept AHA | Wofasept AHA | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Otovita® Professional Handgel | Otovita® Professional Handgel | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0001 1-1 | EU-0027707-0001 1-1 | EU-0027707-0001 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 62,7 % (w/w) |
7.2. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Budenat® Protect Hand D807 | Budenat® Protect Hand D807 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Rodalon Hand Sanitizer | Rodalon Hand Sanitizer | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0002 1-1 | EU-0027707-0002 1-1 | EU-0027707-0002 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 63 % (w/w) |
7.3. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Handsteril OG | Handsteril OG | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Disinfection for Hands OG | Disinfection for Hands OG | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | 2-Propanol 70% | 2-Propanol 70% | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Isopropylalkohol Königseer Biozid | Isopropylalkohol Königseer Biozid | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Isogel Königseer Biozid Plus | Isogel Königseer Biozid Plus | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Isogel Königseer Biozid | Isogel Königseer Biozid | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | ISO 70 | ISO 70 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Brensolv K68 | Brensolv K68 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Isopropanol 70 Biocide | Isopropanol 70 Biocide | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Isopropanol 70 | Isopropanol 70 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HÄNDE-DES fluid | HÄNDE-DES fluid | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Laveo HD | Laveo HD | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Bäktec Händedesinfektion | Bäktec Händedesinfektion | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0003 1-1 | EU-0027707-0003 1-1 | EU-0027707-0003 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 70 % (w/w) |
7.4. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Handsteril OG blau | Handsteril OG blau | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0004 1-1 | EU-0027707-0004 1-1 | EU-0027707-0004 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 65 % (w/w) |
7.5. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Easysept | Easysept | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0005 1-1 | EU-0027707-0005 1-1 | EU-0027707-0005 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 63 % (w/w) |
7.6. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Witty-Lavalin D | Witty-Lavalin D | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | proCura Spray PUR | proCura Spray PUR | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Orlin Suprades HD | Orlin Suprades HD | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Esept | Esept | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Bio Tec Des HD | Bio Tec Des HD | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0006 1-1 | EU-0027707-0006 1-1 | EU-0027707-0006 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 63,1 % (w/w) |
7.7. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Curacid HD-sept | Curacid HD-sept | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0007 1-1 | EU-0027707-0007 1-1 | EU-0027707-0007 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 62,8 % (w/w) |
7.8. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Esept Gel | Esept Gel | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0008 1-1 | EU-0027707-0008 1-1 | EU-0027707-0008 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 63,4 % (w/w) |
7.9. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | HD18 Mano Germs | HD18 Mano Germs | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0009 1-1 | EU-0027707-0009 1-1 | EU-0027707-0009 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 63 % (w/w) |
7.10. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Deogel Mani | Deogel Mani | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Deovet | Deovet | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Deogel Hands | Deogel Hands | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Deomed | Deomed | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Dermigel profumato | Dermigel profumato | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0010 1-1 | EU-0027707-0010 1-1 | EU-0027707-0010 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 70 % (w/w) |
7.11. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Isogel | Isogel | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Vetgel | Vetgel | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Icfgel | Icfgel | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Skingel | Skingel | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Sanigel | Sanigel | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Dermigel | Dermigel | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Gel mimani | Gel mimani | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0011 1-1 | EU-0027707-0011 1-1 | EU-0027707-0011 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 70 % (w/w) |
7.12. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Alcodet profumato | Alcodet profumato | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0012 1-1 | EU-0027707-0012 1-1 | EU-0027707-0012 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 70 % (w/w) |
7.13. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Handsan | Handsan | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Manisan | Manisan | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Sanimed | Sanimed | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0013 1-1 | EU-0027707-0013 1-1 | EU-0027707-0013 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 70 % (w/w) |
7.14. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | ELIGEL | ELIGEL | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0014 1-1 | EU-0027707-0014 1-1 | EU-0027707-0014 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 70 % (w/w) |
7.15. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | ELIGEL Perfum | ELIGEL Perfum | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0015 1-1 | EU-0027707-0015 1-1 | EU-0027707-0015 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 70 % (w/w) |
7.16. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Desmila VSI | Desmila VSI | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | mobilomed Skinsoft Expert | mobilomed Skinsoft Expert | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | SiMa CleanTecMano | SiMa CleanTecMano | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Funny Hygienikum | Funny Hygienikum | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Sinco ManoSept | Sinco ManoSept | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0016 1-1 | EU-0027707-0016 1-1 | EU-0027707-0016 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 62,8 % (w/w) |
7.17. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Desmila VSI C | Desmila VSI C | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0017 1-1 | EU-0027707-0017 1-1 | EU-0027707-0017 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 63 % (w/w) |
7.18. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Desmila LSI | Desmila LSI | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | mobilomed Skinsoft Professional | mobilomed Skinsoft Professional | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0018 1-1 | EU-0027707-0018 1-1 | EU-0027707-0018 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 64,7 % (w/w) |
7.19. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Desmila LSI C | Desmila LSI C | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0019 1-1 | EU-0027707-0019 1-1 | EU-0027707-0019 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 64,7 % (w/w) |
7.20. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Desmila LSI pure | Desmila LSI pure | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Mobilomed Skinsoft Sensitiv | Mobilomed Skinsoft Sensitiv | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0020 1-1 | EU-0027707-0020 1-1 | EU-0027707-0020 1-1 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 64,7 % (w/w) |
1. META SPC 2 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 2 identifier
| Identifier | Meta SPC: Meta SPC 2 |
1.2. Suffix to the authorisation number
| Number | 1-2 |
1.3. Product type(s)
| Product type(s) | PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area |
2. META SPC 2 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 2
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| Propan-2-ol | Active substance | 67-63-0 | 200-661-7 | 62,8 - 70 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 2
| Formulation type(s) | Meta SPC 2: XX – Others: Ready-to-Use trigger spray |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
| Hazard statements | H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. |
| Precautionary statements | P101: If medical advice is needed, have product container or label at hand. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P261: Avoid breathing vapours. P261: Avoid breathing spray. P271: Use only outdoors or in a well-ventilated area. P280: Wear eye protection. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER/doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical advice. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local regulations. P501: Dispose of container in accordance with local regulations. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use 1 – Liquid Spray – Small surface disinfection – Professional user
| Product type | PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
| Where relevant, an exact description of the authorised use | Not 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 use 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. - 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 users | professional |
| Pack 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 )
- 2)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 2
Use 2 – Liquid Spray - Disinfection for small food contact surfaces – Professional user
| Product type | PT04: Food and feed area |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - |
| Field(s) of use | indoor use 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. - 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 users | professional |
| Pack 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 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) | Trade name(s) | Trade name(s) | proCura Spray PUR | proCura Spray PUR | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Witty-Express Ultra | Witty-Express Ultra | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Witty-AQUA MEGA | Witty-AQUA MEGA | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Anti-Germ DES ALC-IP | Anti-Germ DES ALC-IP | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | BTS 6000 | BTS 6000 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Bio Tec Des AX | Bio Tec Des AX | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HD 10 Fast Germs | HD 10 Fast Germs | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0021 1-2 | EU-0027707-0021 1-2 | EU-0027707-0021 1-2 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 63,1 % (w/w) |
7.2. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Isopropanol 70 Biocide | Isopropanol 70 Biocide | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Isopropanol 70 | Isopropanol 70 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Isopropylalkohol Königseer Biozid | Isopropylalkohol Königseer Biozid | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Isogel Königseer Biozid Plus | Isogel Königseer Biozid Plus | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Füllersteril PPP | Füllersteril PPP | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Isopropylalkohol 70% Gew. | Isopropylalkohol 70% Gew. | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Fast Germs | Fast Germs | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | BACTINYL IPA 70 % | BACTINYL IPA 70 % | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | SAFE CLEANER SR | SAFE CLEANER SR | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Isopropylalkohol Königseer Flächen Biozid | Isopropylalkohol Königseer Flächen Biozid | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Isonet | Isonet | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Isonet AL | Isonet AL | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Sanificante Alcolico | Sanificante Alcolico | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Isogerm | Isogerm | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Isogerm AL | Isogerm AL | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Isonet PU | Isonet PU | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Alidet | Alidet | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Sanocasa | Sanocasa | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Frigosano | Frigosano | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Hygien Food | Hygien Food | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Medicalsan | Medicalsan | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Alcohol Sanitized | Alcohol Sanitized | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Alkosan | Alkosan | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Biofarm | Biofarm | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Allkill | Allkill | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | DETERQUAT PRO SR | DETERQUAT PRO SR | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Galtec Isoprop Bactericide | Galtec Isoprop Bactericide | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Amphisol 70 | Amphisol 70 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | AISW 100 | AISW 100 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Steril Spray PPP | Steril Spray PPP | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | IsoPure Flächendesinfektion | IsoPure Flächendesinfektion | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | ALK-DES | ALK-DES | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Laveo FDS | Laveo FDS | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Bäktec Flächendesinfektion | Bäktec Flächendesinfektion | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Maschinen- und Flächendesinfektion PPP | Maschinen- und Flächendesinfektion PPP | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Brensolv K68 | Brensolv K68 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | ISO 70 | ISO 70 | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0022 1-2 | EU-0027707-0022 1-2 | EU-0027707-0022 1-2 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 70 % (w/w) |
7.3. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Budenat® Rapid Effect D 446 | Budenat® Rapid Effect D 446 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | IPA 300 | IPA 300 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Easydes IPA | Easydes IPA | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Sonet | Sonet | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Isonet Forte | Isonet Forte | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Isosan Forte | Isosan Forte | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Germisan | Germisan | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Sanivet | Sanivet | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Alidet Forte | Alidet Forte | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Germodet | Germodet | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Isoclean | Isoclean | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Alcohol Sanitized Strong | Alcohol Sanitized Strong | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Alkosan Strong | Alkosan Strong | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Isonet Strong | Isonet Strong | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Desmila HSI | Desmila HSI | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Vetasept pur | Vetasept pur | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0023 1-2 | EU-0027707-0023 1-2 | EU-0027707-0023 1-2 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 63 % (w/w) |
7.4. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Isopropanol/Wasser 65/35% | Isopropanol/Wasser 65/35% | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0024 1-2 | EU-0027707-0024 1-2 | EU-0027707-0024 1-2 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 65 % (w/w) |
7.5. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Curacid Food Rapid | Curacid Food Rapid | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Dr. Desi Küchendesinfektion | Dr. Desi Küchendesinfektion | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0025 1-2 | EU-0027707-0025 1-2 | EU-0027707-0025 1-2 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 62,8 % (w/w) |
7.6. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Deogerm | Deogerm | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Deosan | Deosan | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Medicaldeo | Medicaldeo | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Deonet | Deonet | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Deofloor | Deofloor | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Sanocasa Profumato | Sanocasa Profumato | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0026 1-2 | EU-0027707-0026 1-2 | EU-0027707-0026 1-2 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 63 % (w/w) |
7.7. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Desmila HSI C | Desmila HSI C | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Vetasept Lemon | Vetasept Lemon | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0027 1-2 | EU-0027707-0027 1-2 | EU-0027707-0027 1-2 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 63 % (w/w) |
7.8. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Desmila HSI D | Desmila HSI D | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Vetasept Fresh | Vetasept Fresh | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0028 1-2 | EU-0027707-0028 1-2 | EU-0027707-0028 1-2 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 63 % (w/w) |
7.9. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Desmila HSI P | Desmila HSI P | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Vetasept Pfirsich | Vetasept Pfirsich | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0029 1-2 | EU-0027707-0029 1-2 | EU-0027707-0029 1-2 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 63 % (w/w) |
7.10. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | Desmila AFI | Desmila AFI | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Hygienic I | Hygienic I | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0027707-0030 1-2 | EU-0027707-0030 1-2 | EU-0027707-0030 1-2 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Propan-2-ol | Active substance | Active substance | 67-63-0 | 67-63-0 | 200-661-7 | 64,7 % (w/w) |
1. META SPC 3 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 3 identifier
| Identifier | Meta SPC: Meta SPC 3 |
1.2. Suffix to the authorisation number
| Number | 1-3 |
1.3. Product type(s)
| Product type(s) | PT01: Human hygiene |
2. META SPC 3 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 3
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
|---|---|---|---|---|---|
| Propan-2-ol | Active substance | 67-63-0 | 200-661-7 | 62,7 - 70 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 3
| Formulation type(s) | Meta SPC 3: CL - Contact gel or Liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
| Hazard statements | H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. |
| Precautionary statements | P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P261: Avoid breathing vapours. P261: Avoid breathing spray. P271: Use only outdoors or in a well-ventilated area. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER/doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical advice. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local regulations. P501: Dispose of container in accordance with local regulations. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use 1 – Contact Gel or Liquid - Hygienic handrub - Non-professional user
| Product type | PT01: Human hygiene |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target 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 use 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. - Number and timing of application: Up to 5 disinfections per day, 5 day(s) per week |
| Category(ies) of users | general public (non-professional) |
| Pack sizes and packaging material | Bottle 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 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.
- 2)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
-
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
7.1. Trade name(s), authorisation number and specific composition of each individual product
Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.
This text is published under EUR-Lex's own terms of reuse, not a Legalize or public-domain licence.
EUR-Lex
Creative Commons Attribution 4.0 International (CC BY 4.0)
© European Union, https://eur-lex.europa.eu — Source: EUR-Lex (Publications Office of the European Union). Reused under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Only EU legislation published in the printed Official Journal of the European Union is deemed authentic; consolidated texts are reproduced here for documentation purposes and have been reformatted to Markdown.