ANNEX

Summary of product characteristics for a biocidal product family

Brenntag GmbH Propan-2-ol Product Family

Product type 1 – Human hygiene (Disinfectants)

Product type 4 – Food and feed area (Disinfectants)

Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Authorisation number: EU-0027707-0000

R4BP asset number: EU-0027707-0000

PART I

FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION

1.1. Family name

Name Brenntag GmbH Propan-2-ol Product Family

1.2. Product type(s)

Product type(s) PT01 – Human hygiene (Disinfectants) PT04 – Food and feed area (Disinfectants) PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

1.3. Authorisation holder

Name and address of the authorisation holder Name Brenntag GmbH Address Messeallee 11, 45131 Essen Germany Authorisation number EU-0027707-0000 R4BP asset number EU-0027707-0000 Date of the authorisation 7 December 2022 Expiry date of the authorisation 30 November 2032

1.4. Manufacturer(s) of the biocidal products

Name of manufacturer Kesla Pharma Wolfen GmbH Address of manufacturer Kesla-Str. 1, 06803 Bitterfeld Germany Location of manufacturing sites Kesla-Str. 1, 06803 Bitterfeld Germany





Name of manufacturer Dreve GmbH Address of manufacturer Max-Planck-Str. 31, 59423 Unna Germany Location of manufacturing sites Kesla Pharma Wolfen GmbH, 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 Fraunhoferstr. 17, 87700 Memmingen Germany





Name of manufacturer Wigol W. Stache GmbH Address of manufacturer Textorstr. 2, 67547 Worms Germany Location of manufacturing sites Textorstr. 2, 67547 Worms Germany





Name of manufacturer KiiltoClean Oy Address of manufacturer Tengströminkatu 6, FI-20630 Turku Finland Location of manufacturing sites 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 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 An der Mole 5, 76189 Karlsruhe Germany





Name of manufacturer Pro-cura Hy-med GmbH Address of manufacturer Stresemannstrasse 364, 22761 Hamburg Germany Location of manufacturing sites A.F.P., Otto-Brenner-Str. 16, 21337 Lüneburg Germany





Name of manufacturer Pico-medical GmbH Address of manufacturer Fangdieckstr. 24, 22547 Hamburg Germany Location of manufacturing sites A.F.P., Otto-Brenner-Str. 16, 21337 Lüneburg Germany





Name of manufacturer Anti-Germ International GmbH Address of manufacturer Oberbrühlstr. 16, 87700 Memmingen Germany Location of manufacturing sites Oberbrühlstr. 16, 87700 Memmingen Germany





Name of manufacturer LCI FLOWEY Address of manufacturer 2 ZAC Klengbusbierg, 7795 Bissen Luxembourg Location of manufacturing sites 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 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 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 Via Cusago 150/4, 20158 Milano (MI) Italy





Name of manufacturer I.C.F. Srl Address of manufacturer Via G.B. Benzoni 50, 26020 Palazzo Pignano (CR) Italy Location of manufacturing sites Via G.B. Benzoni 50, 26020 Palazzo Pignano (CR) Italy





Name of manufacturer Brenntag SA Address of manufacturer 90 Avenue du Progrès, 69 680 Chassieu France Location of manufacturing sites 90 Avenue du Progrès, 69 680 Chassieu France





Name of manufacturer Brenntag GmbH Address of manufacturer Stinnes-Platz 1, 45472 Muelheim a.d. Ruhr Germany Location of manufacturing sites Stinnes-Platz 1, 45472 Muelheim a.d. Ruhr Germany





Name of manufacturer BCD Chemie GmbH Address of manufacturer Schellerdamm 16, 21079 Hamburg Germany Location of manufacturing sites Schellerdamm 16, 21079 Hamburg Germany





Name of manufacturer HYDRACHIM Address of manufacturer Z.A. ROUTE DE ST POIX, 35370 LE PERTRE France Location of manufacturing sites 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 Wandalenstrasse 6, 86343 Königsbrunn Germany





Name of manufacturer Burgess Galvin & Co Address of manufacturer Jamestown Road, 11 Finglas, Dublin Ireland Location of manufacturing sites Jamestown Road, 11 Finglas, Dublin Ireland





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





Name of manufacturer Brenntag Schweizerhall Address of manufacturer Elsässerstrasse 231, 4056 Basel Switzerland Location of manufacturing sites 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 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 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 TOGHER INDUSTRIAL EST, T12KPF2 CORK, DUBLIN Ireland





Name of manufacturer AF International, Electrolube: Divisions of H K Wentworth Ltd Address of manufacturer AASHBY PARK, COALFIELD WAY, ASHBY DE LA ZOUCH, LE65 1JF LEICESTERSHIRE United Kingdom Location of manufacturing sites AASHBY PARK, COALFIELD WAY, ASHBY DE LA ZOUCH, LE65 1JF LEICESTERSHIRE United Kingdom





Name of manufacturer Bello Mondo bvba Address of manufacturer Helststraat 150-159, 2630 Aartselaar Belgium Location of manufacturing sites Laboratoria Smeets N.V., Fotografielaan 42, B-2610 Antwerpen-Wilrijk Belgium





Name of manufacturer CERICHEM BIOPHARM SRL Address of manufacturer Viale Einaudi snc (z.i.), 71042 Cerignola (FG) Italy Location of manufacturing sites Viale Einaudi snc (z.i.), 71042 Cerignola (FG) Italy





Name of manufacturer Otto Fischar GmbH & Co. KG Address of manufacturer Kaiserstr. 221, 66133 Saarbruecken Germany Location of manufacturing sites Kaiserstr. 221, 66133 Saarbruecken Germany





Name of manufacturer Caesar & Loretz GmbH Address of manufacturer Herderstr. 31, 40721 Hilden Germany Location of manufacturing sites 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 Rauentalshöhe 4, 56073 Koblenz 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 Location of manufacturing sites 4999 Scenic Highway, LA 70897 Baton Rouge, Louisiana United States





Active substance Propan-2-ol Name of manufacturer Shell Nederland Raffinaderij B.V. Address of manufacturer Vondelingenweg 601, Vodelingenenplaat, 3196 KK Rotterdam Netherlands Location of manufacturing sites Vondelingenweg 601, Vodelingenenplaat, 3196 KK Rotterdam Netherlands





Active substance Propan-2-ol Name of manufacturer INEOS Solvents Germany GmbH Address of manufacturer Römerstrasse 733, 47443 Moers Germany Location of manufacturing sites Römerstrasse 733, 47443 Moers Germany Shamrockstraße 88, 44623 Herne Germany

2. PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1. Qualitative and quantitative information on the composition of the family

Common name IUPAC name Function CAS number EC number Content (%) Min Max Propan-2-ol Active Substance 67-63-0 200-661-7 62,7 70,0

2.2. Type(s) of formulation

Formulation(s) Meta SPC 1: CL – Contact gel or Liquid Meta SPC 3: CL – Contact gel or Liquid Meta SPC 2: XX – Others: Ready-to-Use trigger spray

PART II

SECOND INFORMATION LEVEL – META SPC(S)

META SPC 1

1. META SPC 1 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 1 identifier

Identifier Meta SPC 1

1.2. Suffix to the authorisation number

Number 1-1

1.3. Product type(s)

Product type(s) PT01 – Human hygiene (Disinfectants)

2. META SPC 1 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 1

Common name IUPAC name Function CAS number EC number Content (%) Min Max Propan-2-ol Active Substance 67-63-0 200-661-7 62,7 70,0

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

Formulation(s) Meta SPC 1: CL – Contact gel or Liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements Highly flammable liquid and vapour. Causes serious eye irritation. May cause drowsiness or dizziness. Repeated exposure may cause skin dryness or cracking. Precautionary statements If medical advice is needed, have product container or label at hand. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking. Keep container tightly closed. Avoid breathing vapours. Avoid breathing spray. Use only outdoors or in a well-ventilated area. Wear eye protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Call a POISON CENTER/doctor if you feel unwell. If eye irritation persists:Get medical advice. If eye irritation persists:Get medical attention. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of contents to in accordance with local regulations. Dispose of container to in accordance with local regulations.

4. AUTHORISED USE(S) OF THE META SPC 1

4.1. Use description

Table 1

Use # 1 – Use 1 – Contact Gel or Liquid – Hygienic handrub – Professional user

Product type PT01 – Human hygiene (Disinfectants) 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 For professional use only. For use in private, public, healthcare and industrial areas and in areas for professional activities. Application method(s) Method: Direct application to both hands, rubbing Detailed description: - Application rate(s) and frequency Application Rate: 3 ml applied to one hand and complete surface of both hands are moistened and rubbed for 60 seconds per application. Dilution (%): - Number and timing of application: Up to 25 disinfections per day, 5 day(s) per week Category(ies) of 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 (1) OF THE META SPC 1

5.1. Instructions for use

1) For professional use only.

2) Products must be shaken before use.

3) Only apply on dry and visibly clean hands.

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) Wofasept AHA Market area: EU Otovita® Professional Handgel Market area: EU Authorisation number EU-0027707-0001 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 62,7

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

Trade name(s) Budenat® Protect Hand D807 Market area: EU Authorisation number EU-0027707-0002 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 63,0

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

Trade name(s) Handsteril OG Market area: EU Disinfection for Hands OG Market area: EU 2-Propanol 70 % Market area: EU Isopropylalkohol Königseer Biozid Market area: EU Isogel Königseer Biozid Plus Market area: EU Isogel Königseer Biozid Market area: EU ISO 70 Market area: EU Brensolv K68 Market area: EU Isopropanol 70 Biocide Market area: EU Isopropanol 70 Market area: EU Hand- und Oberflächendesinfektion Market area: EU Authorisation number EU-0027707-0003 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 70,0

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

Trade name(s) Handsteril OG blau Market area: EU Authorisation number EU-0027707-0004 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 65,0

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

Trade name(s) Easysept Market area: EU Authorisation number EU-0027707-0005 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 63,0

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

Trade name(s) Witty-Lavalin D Market area: EU proCura Spray PUR Market area: EU Orlin Suprades HD Market area: EU Esept Market area: EU Bio Tec Des HD Market area: EU Authorisation number EU-0027707-0006 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 63,1

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

Trade name(s) Curacid HD-sept Market area: EU Authorisation number EU-0027707-0007 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 62,8

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

Trade name(s) Esept Gel Market area: EU Authorisation number EU-0027707-0008 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 63,4

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

Trade name(s) Mano Germs Market area: EU Authorisation number EU-0027707-0009 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 63,0

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

Trade name(s) Deogel Mani Market area: EU Deovet Market area: EU Deogel Hands Market area: EU Deomed Market area: EU Dermigel profumato Market area: EU Authorisation number EU-0027707-0010 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 70,0

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

Trade name(s) Isogel Market area: EU Vetgel Market area: EU Icfgel Market area: EU Skingel Market area: EU Sanigel Market area: EU Dermigel Market area: EU Gel mimani Market area: EU Authorisation number EU-0027707-0011 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 70,0

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

Trade name(s) Alcodet profumato Market area: EU Authorisation number EU-0027707-0012 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 70,0

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

Trade name(s) Handsan Market area: EU Manisan Market area: EU Sanimed Market area: EU Authorisation number EU-0027707-0013 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 70,0

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

Trade name(s) ELIGEL Market area: EU Authorisation number EU-0027707-0014 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 70,0

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

Trade name(s) ELIGEL Perfum Market area: EU Authorisation number EU-0027707-0015 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 70,0

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

Trade name(s) Desmila VSI Market area: EU mobilomed Skinsoft Expert Market area: EU SiMa CleanTecMano Market area: EU Funny Hygienikum Market area: EU Authorisation number EU-0027707-0016 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 62,8

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

Trade name(s) Desmila VSI C Market area: EU Authorisation number EU-0027707-0017 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 63,0

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

Trade name(s) Desmila LSI Market area: EU mobilomed Skinsoft Professional Market area: EU Authorisation number EU-0027707-0018 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 64,7

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

Trade name(s) Desmila LSI C Market area: EU Authorisation number EU-0027707-0019 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 64,7

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

Trade name(s) Desmila LSI pure Market area: EU Authorisation number EU-0027707-0020 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 64,7

META SPC 2

1. META SPC 2 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 2 identifier

Identifier Meta SPC 2

1.2. Suffix to the authorisation number

Number 1-2

1.3. Product type(s)

Product type(s) PT04 – Food and feed area (Disinfectants) PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

2. META SPC 2 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 (%) Min Max Propan-2-ol Active Substance 67-63-0 200-661-7 62,8 70,0

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

Formulation(s) Meta SPC 2: XX – Others: Ready-to-Use trigger spray

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

Hazard statements Highly flammable liquid and vapour. Causes serious eye irritation. May cause drowsiness or dizziness. Repeated exposure may cause skin dryness or cracking. Precautionary statements If medical advice is needed, have product container or label at hand. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking. Keep container tightly closed. Avoid breathing vapours. Avoid breathing spray. Use only outdoors or in a well-ventilated area. Wear eye protection. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Call a POISON CENTER/doctor if you feel unwell. If eye irritation persists:Get medical advice. If eye irritation persists:Get medical attention. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of contents to in accordance with local regulations. Dispose of container to in accordance with local regulations.

4. AUTHORISED USE(S) OF THE META SPC 2

4.1. Use description

Table 2

Use # 1 – Use 1 – Liquid Spray – Small surface disinfection – Professional user

Product type PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) 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 Disinfection of small non-porous surfaces, materials, equipment and furniture in private, public, healthcare, industrial areas and in areas for professional activities. Application method(s) Method: Spraying Detailed description: - Application rate(s) and frequency Application Rate: For surface disinfection a ready-to-use spray solution (20 ml/m2) is applied on surfaces at room temperature. Dilution (%): - Number and timing of application: Application according to requirements, one application per use, 4 times per day. Small surface disinfection(other than healthcare): Bactericidal and yeasticidal: contact time at least 1 min In healthcare area: Bactericidal and yeasticidal: contact time at least 5 min Category(ies) of 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 3

Use # 2 – Use 2 – Liquid Spray – Disinfection for small food contact surfaces – Professional user

Product type PT04 – Food and feed area (Disinfectants) 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 Disinfection of small non-porous surfaces in food sector or food processing industries (including breweries, dairy industry and meat industry). Application method(s) Method: Spraying Detailed description: - Application rate(s) and frequency Application Rate: For surface disinfection a ready-to-use spray solution (20 ml/m2) is applied on surfaces at room temperature. Dilution (%): - Number and timing of application: Application according to requirements, one application per use, 4 times per day. Small surface disinfection: Bactericidal and yeasticidal: contact time at least 1 min In Breweries/meat industry: Bactericidal and yeasticidal: contact time at least 5 min In dairy industry: Bactericidal and yeasticidal: contact time at least 15 min Category(ies) of 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 (2) OF THE META SPC 2

5.1. Instructions for use

1) Products must be shaken before use.

2) Do not apply more than 20 mL/m2.

3) Used wipes must be disposed in a closed container.

5.2. Risk mitigation measures

1) Avoid contact with eyes.

2) For refilling a funnel must be applied.

3) The product must only be applied for disinfection of small surfaces.

4) Keep out of reach of children and pets.

5) Use only in well-ventilated areas.

6) Keep children and pets away from rooms where disinfection is taking place.

7) Provide adequate ventilation before children and pets enter treated rooms.

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

1) IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

2) IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.

5.4. Instructions for safe disposal of the product and its packaging

1) Product: Disposal together with normal waste is not allowed. Special disposal required according to local regulations.

2) Do not let product enter drains.

3) Contact waste disposal services.

4) Contaminated packaging: Empty contaminated packaging thoroughly. They can be recycled after thorough and proper cleaning. Packaging that cannot be cleaned are to be disposed of in the same manner as the product.

5) Do not burn, or use a cutting torch on, the empty drum. Risk of explosion.

5.5. Conditions of storage and shelf-life of the product under normal conditions of storage

1) Store in a well-ventilated place.

2) Keep cool.

3) Keep container tightly closed.

4) Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

5) Shelf-life: 24 months

6. OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

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

Trade name(s) proCura Spray PUR Market area: EU Witty-Express Ultra Market area: EU Witty-AQUA MEGA Market area: EU Anti-Germ DES ALC-IP Market area: EU BTS 6000 Market area: EU Bio Tec Des AX Market area: EU Authorisation number EU-0027707-0021 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 63,1

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

Trade name(s) Isopropanol 70 Biocide Market area: EU Isopropanol 70 Market area: EU Isopropylalkohol Königseer Biozid Market area: EU Isogel Königseer Biozid Plus Market area: EU Gold Market area: EU Füllersteril PPP Market area: EU Isopropylalkohol 70 % Gew. Market area: EU Fast Germs Market area: EU BACTINYL IPA 70 % Market area: EU SAFE CLEANER SR Market area: EU Isopropylalkohol Königseer Flächen Biozid Market area: EU Isonet Market area: EU Isonet AL Market area: EU Sanificante Alcolico Market area: EU Isogerm Market area: EU Isogerm AL Market area: EU Isonet PU Market area: EU Alidet Market area: EU Sanocasa Market area: EU Frigosano Market area: EU Hygien Food Market area: EU Medicalsan Market area: EU Alcohol Sanitized Market area: EU Alkosan Market area: EU Biofarm Market area: EU Allkill Market area: EU DETERQUAT PRO SR Market area: EU Galtec Isoprop Bactericide Market area: EU Amphisol 70 Market area: EU AISW 100 Market area: EU Steril Spray PPP Market area: EU Hand- und Oberflächendesinfektion Market area: EU Authorisation number EU-0027707-0022 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 70,0

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

Trade name(s) Budenat® Rapid Effect D 446 Market area: EU IPA 300 Market area: EU Easydes IPA Market area: EU Sonet Market area: EU Sonet Forte Market area: EU Isosan Forte Market area: EU Germisan Market area: EU Sanivet Market area: EU Alidet Forte Market area: EU Germodet Market area: EU Isoclean Market area: EU Alcohol Sanitized Strong Market area: EU Alkosan Strong Market area: EU Isonet Strong Market area: EU Desmila HSI Market area: EU Vetasept pur Market area: EU Authorisation number EU-0027707-0023 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 63,0

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

Trade name(s) Isopropanol/Wasser 65/35 % Market area: EU Authorisation number EU-0027707-0024 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 65,0

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

Trade name(s) Curacid Food Rapid Market area: EU Dr Desi Küchendesinfektion Market area: EU Authorisation number EU-0027707-0025 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 62,8

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

Trade name(s) Deogerm Market area: EU Deosan Market area: EU Medicaldeo Market area: EU Deonet Market area: EU Deofloor Market area: EU Sanocasa Profumato Market area: EU Authorisation number EU-0027707-0026 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 63,0

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

Trade name(s) Desmila HSI C Market area: EU Vetasept Lemon Market area: EU Authorisation number EU-0027707-0027 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 63,0

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

Trade name(s) Desmila HSI D Market area: EU Vetasept Fresh Market area: EU Authorisation number EU-0027707-0028 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 63,0

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

Trade name(s) Desmila HSI P Market area: EU Vetasept Pfirsich Market area: EU Authorisation number EU-0027707-0029 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 63,0

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

Trade name(s) Desmila AFI Market area: EU Hygienic I Market area: EU Authorisation number EU-0027707-0030 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 64,7

META SPC 3

1. META SPC 3 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 3 identifier

Identifier Meta SPC 3

1.2. Suffix to the authorisation number

Number 1-3

1.3. Product type(s)

Product type(s) PT01 – Human hygiene (Disinfectants)

2. META SPC 3 COMPOSITION

2.1. Qualitative and quantitative information on the composition of the meta SPC 3

Common name IUPAC name Function CAS number EC number Content (%) Min Max Propan-2-ol Active Substance 67-63-0 200-661-7 62,7 70,0

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

Formulation(s) Meta SPC 3: CL – Contact gel or Liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

Hazard statements Highly flammable liquid and vapour. Causes serious eye irritation. May cause drowsiness or dizziness. Repeated exposure may cause skin dryness or cracking. Precautionary statements If medical advice is needed, have product container or label at hand. Keep out of reach of children. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking. Keep container tightly closed. Avoid breathing vapours. Avoid breathing spray. Use only outdoors or in a well-ventilated area. IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing. Call a POISON CENTER/doctor if you feel unwell. If eye irritation persists:Get medical advice. If eye irritation persists:Get medical attention. Store in a well-ventilated place.Keep cool. Store locked up. Dispose of contents to in accordance with local regulations. Dispose of container to in accordance with local regulations.

4. AUTHORISED USE(S) OF THE META SPC 3

4.1. Use description

Table 4

Use # 1 – Use 1 – Contact Gel or Liquid – Hygienic handrub – Non-professional user

Product type PT01 – Human hygiene (Disinfectants) 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 For use in private and public areas. Application method(s) Method: Direct application to both hands, rubbing Detailed description: - Application rate(s) and frequency Application Rate: 3 ml applied to one hand and complete surface of both hands are moistened and rubbed for 60 seconds per application. Dilution (%): - Number and timing of application: Up to 5 disinfections per day, 5 day(s) per week Category(ies) of 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 (3) OF THE META SPC 3

5.1. Instructions for use

1) Comply with the instructions for use.

2) Products must be shaken before use.

3) Only apply on dry and visibly clean hands.

4) For hand disinfection a ready-to-use gel or liquid (3 ml) is poured into the palms of one hand and the complete surface of both hands are moistened and rubbed for 60 seconds per application.

5) The authorisation holder has to specify the typical application rate in a simple, easily understandable form on the label: — Trigger spray: Apply 3 or 4 spray strokes (depending on the trigger spray cap) — Pump spray: Apply 3 pump strokes — Bottle: Visual observation

5.2. Risk mitigation measures

1) Avoid contact with eyes.

2) Use by children only under supervision of an adult.

3) Use only in well-ventilated areas.

5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

1) If medical advice is needed, have product container or label at hand.

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

Trade name(s) Frend Hand Sanitiser Gel Market area: EU Authorisation number EU-0027707-0031 1-3 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 65,3

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

Trade name(s) Biogat H-Des Market area: EU Authorisation number EU-0027707-0032 1-3 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 70,0

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

Trade name(s) Neo-Amisept Market area: EU Authorisation number EU-0027707-0033 1-3 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active Substance 67-63-0 200-661-7 63,0

(1) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.

(2) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.

(3) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.