Commission Implementing Regulation (EU) 2026/1114 of 26 May 2026 amending Implementing Regulation (EU) 2022/2252 granting a Union authorisation for the biocidal product family Brenntag GmbH Propan-2-ol Product Family as regards administrative changes

Official Journal EN of the European Union L series 2026/1114 27.5.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/1114 of 26 May 2026 amending Implementing Regulation (EU) 2022/2252 granting a Union authorisation for the biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’ as regards administrative changes (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products(1), and in particular Article 50(2) thereof,

Whereas:

(1) On 11 November 2022, Commission Implementing Regulation (EU) 2022/2252(2)granted a Union authorisation, under number EU-0027707-0000, to Brenntag GmbH for the making available on the market and use of the biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’. The Annex to that Implementing Regulation provides the summary of product characteristics for that biocidal product family.

(2) On 14 October 2024, Brenntag GmbH submitted to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) 354/2013(3), notifications of administrative changes to the Union authorisation for the biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’, recorded in the Register for Biocidal Products under the case number BC-SP100423-35. The notified proposed changes to that authorisation concern the addition, deletion and modifications of trade names, the addition and deletion of nine product manufacturers, the addition of three manufacturing sites and the deletion of one manufacturing site of the authorisation holder.

(3) On 8 November 2024, the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, opinion(4) on the notified administrative changes. In its opinion, the Agency concluded that the proposed changes are administrative changes as referred to in Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 1, Sections 1 and 2 of the Annex to Implementing Regulation

(EU) No 354/2013, and that, after the implementation of those changes, the conditions of Article 19 of Regulation

(EU) No 528/2012 will still be met.

(4) On 8 November 2024, the Agency transmitted to the Commission a revised summary of product characteristics for the biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’ in all official languages of the Union, covering the administrative changes requested, in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.

(5) The Commission concurs with the opinion of the Agency and therefore considers it appropriate to amend the Union authorisation of the biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’ by introducing the administrative changes requested by Brenntag GmbH.

(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(2) Commission Implementing Regulation (EU) 2022/2252 of 11 November 2022 granting a Union authorisation for the biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’ (OJ L 297, 17.11.2022, p. 1, ELI: http://data.europa.eu/eli/reg_impl/ 2022/2252/oj).

(3) Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4, ELI: http://data.europa.

eu/eli/reg_impl/2013/354/oj).

(4) ECHA opinion UAD-C-1776201-36-00/F of 8 November 2024 on administrative changes of the Union authorisation of the biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’, available on: https://echa.europa.eu/opinions-on-union-authorisation.

ELI: http://data.europa.eu/eli/reg_impl/2026/1114/oj 1/34EN OJ L, 27.5.2026

(6) Except for the administrative changes, all other information included in the summary of product characteristics of ‘Brenntag GmbH Propan-2-ol Product Family’, as set out in the Annex to Implementing Regulation (EU) 2022/2252, remains unchanged.

(7) In order to enhance clarity and to ease the access of users and interested parties to the consolidated version of the summary of product characteristics which is to be published by the Agency, the Annex to Implementing Regulation

(EU) 2022/2252 should be replaced in its entirety. Due to a change in the format used for the generation of the summary of product characteristics in the Register for Biocidal Products in February 2024, the summary of product characteristics in that Annex should also include some minor editorial and layout changes.

(8) Implementing Regulation (EU) 2022/2252 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1 The Annex to Implementing Regulation (EU) 2022/2252 is replaced by the text set out in the Annex to this Regulation.

Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 26 May 2026.

For the Commission The President Ursula VON DER LEYEN 2/34 ELI: http://data.europa.eu/eli/reg_impl/2026/1114/ojEN OJ L, 27.5.2026 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 numberEU-0027707-0000 R4BP asset numberEU-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 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

ELI: http://data.europa.eu/eli/reg_impl/2026/1114/oj 3/34EN OJ L, 27.5.2026 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 4/34 ELI: http://data.europa.eu/eli/reg_impl/2026/1114/ojEN OJ L, 27.5.2026 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

ELI: http://data.europa.eu/eli/reg_impl/2026/1114/oj 5/34EN OJ L, 27.5.2026 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 6/34 ELI: http://data.europa.eu/eli/reg_impl/2026/1114/ojEN OJ L, 27.5.2026 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

ELI: http://data.europa.eu/eli/reg_impl/2026/1114/oj 7/34EN OJ L, 27.5.2026 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) 8/34 ELI: http://data.europa.eu/eli/reg_impl/2026/1114/ojEN OJ L, 27.5.2026 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 67-63-0 200-661-7 62,7 - 70 % (w/w) substance

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

ELI: http://data.europa.eu/eli/reg_impl/2026/1114/oj 9/34EN OJ L, 27.5.2026

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 67-63-0 200-661-7 62,7 - 70 % (w/w) substance

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 Not relevant authorised use 10/34 ELI: http://data.europa.eu/eli/reg_impl/2026/1114/ojEN OJ L, 27.5.2026 Target organism(s) (including development Scientific name: Bacteria (incl. Mycobacteria), stage) 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.

ELI: http://data.europa.eu/eli/reg_impl/2026/1114/oj 11/34EN OJ L, 27.5.2026

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.

12/34 ELI: http://data.europa.eu/eli/reg_impl/2026/1114/ojEN OJ L, 27.5.2026

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/m3for 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 Market area: EU AHA Otovita® Market area: EU Professional Handgel Authorisation number EU-0027707-0001 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 62,7 % (w/w) substance

7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Budenat® Market area: EU Protect Hand D807

Rodalon Hand Market area: EU Sanitizer Authorisation number EU-0027707-0002 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 63 % (w/w) substance

ELI: http://data.europa.eu/eli/reg_impl/2026/1114/oj 13/34EN OJ L, 27.5.2026

7.3. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Handsteril OG Market area: EU

Disinfection Market area: EU for Hands OG 2-Propanol Market area: EU 70% Isopropylalko­ Market area: EU hol Königseer Biozid

Isogel Market area: EU Königseer Biozid Plus

Isogel Market area: EU Königseer Biozid ISO 70 Market area: EU Brensolv K68 Market area: EU

Isopropanol Market area: EU 70 Biocide

Isopropanol Market area: EU 70 HÄNDE-DES Market area: EU fluid

Laveo HD Market area: EU Bäktec Market area: EU Händedesin­ fektion Authorisation number EU-0027707-0003 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 70 % (w/w) substance

7.4. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Handsteril OG Market area: EU blau Authorisation number EU-0027707-0004 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 65 % (w/w) substance 14/34 ELI: http://data.europa.eu/eli/reg_impl/2026/1114/ojEN OJ L, 27.5.2026

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 67-63-0 200-661-7 63 % (w/w) substance

7.6. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Witty-Lavalin Market area: EU D

proCura Spray Market area: EU PUR

Orlin Market area: EU Suprades HD

Esept Market area: EU

Bio Tec Des Market area: EU HD Authorisation number EU-0027707-0006 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 63,1 % (w/w) substance

7.7. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Curacid Market area: EU HD-sept Authorisation number EU-0027707-0007 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 62,8 % (w/w) substance

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 67-63-0 200-661-7 63,4 % (w/w) substance

ELI: http://data.europa.eu/eli/reg_impl/2026/1114/oj 15/34EN OJ L, 27.5.2026

7.9. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) HD18 Mano Market area: EU Germs Authorisation number EU-0027707-0009 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 63 % (w/w) substance

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 Market area: EU profumato Authorisation number EU-0027707-0010 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 70 % (w/w) substance

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 67-63-0 200-661-7 70 % (w/w) substance 16/34 ELI: http://data.europa.eu/eli/reg_impl/2026/1114/ojEN OJ L, 27.5.2026

7.12. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Alcodet Market area: EU profumato Authorisation number EU-0027707-0012 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 70 % (w/w) substance

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 67-63-0 200-661-7 70 % (w/w) substance

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 67-63-0 200-661-7 70 % (w/w) substance

7.15. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) ELIGEL Market area: EU Perfum Authorisation number EU-0027707-0015 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 70 % (w/w) substance

ELI: http://data.europa.eu/eli/reg_impl/2026/1114/oj 17/34EN OJ L, 27.5.2026

7.16. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Desmila VSI Market area: EU

mobilomed Market area: EU Skinsoft Expert

SiMa Market area: EU CleanTecMano

Funny Market area: EU Hygienikum

Sinco Market area: EU ManoSept Authorisation number EU-0027707-0016 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 62,8 % (w/w) substance

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 67-63-0 200-661-7 63 % (w/w) substance

7.18. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Desmila LSI Market area: EU

mobilomed Market area: EU Skinsoft Professional Authorisation number EU-0027707-0018 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 64,7 % (w/w) substance 18/34 ELI: http://data.europa.eu/eli/reg_impl/2026/1114/ojEN OJ L, 27.5.2026

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 67-63-0 200-661-7 64,7 % (w/w) substance

7.20. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Desmila LSI Market area: EU pure

Mobilomed Market area: EU Skinsoft Sensitiv Authorisation number EU-0027707-0020 1-1 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 64,7 % (w/w) substance

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

ELI: http://data.europa.eu/eli/reg_impl/2026/1114/oj 19/34EN OJ L, 27.5.2026

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 67-63-0 200-661-7 62,8 - 70 % (w/ substance 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 Not relevant.

authorised use 20/34 ELI: http://data.europa.eu/eli/reg_impl/2026/1114/ojEN OJ L, 27.5.2026 Target organism(s) (including development Scientific name: Bacteria (incl. Mycobacteria), stage) 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.

ELI: http://data.europa.eu/eli/reg_impl/2026/1114/oj 21/34EN OJ L, 27.5.2026

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 Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria stage) 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) 22/34 ELI: http://data.europa.eu/eli/reg_impl/2026/1114/ojEN OJ L, 27.5.2026

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.

ELI: http://data.europa.eu/eli/reg_impl/2026/1114/oj 23/34EN OJ L, 27.5.2026

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/m3for 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 Market area: EU PUR Witty-Express Market area: EU Ultra Witty-AQUA Market area: EU MEGA 24/34 ELI: http://data.europa.eu/eli/reg_impl/2026/1114/ojEN OJ L, 27.5.2026 Anti-Germ Market area: EU DES ALC-IP BTS 6000 Market area: EU

Bio Tec Des Market area: EU AX HD 10 Fast Market area: EU Germs Authorisation number EU-0027707-0021 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 63,1 % (w/w) substance

7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Isopropanol Market area: EU 70 Biocide

Isopropanol Market area: EU 70 Isopropylalko­ Market area: EU hol Königseer Biozid

Isogel Market area: EU Königseer Biozid Plus Füllersteril Market area: EU PPP Isopropylalko­ Market area: EU hol 70% Gew.

Fast Germs Market area: EU

BACTINYL Market area: EU IPA 70 %

SAFE Market area: EU CLEANER SR Isopropylalko­ Market area: EU hol Königseer Flächen Biozid

Isonet Market area: EU

Isonet AL Market area: EU

Sanificante Market area: EU Alcolico

Isogerm Market area: EU

ELI: http://data.europa.eu/eli/reg_impl/2026/1114/oj 25/34EN OJ L, 27.5.2026

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 Market area: EU Sanitized

Alkosan Market area: EU

Biofarm Market area: EU

Allkill Market area: EU

DETERQUAT Market area: EU PRO SR

Galtec Market area: EU Isoprop Bactericide Amphisol 70 Market area: EU AISW 100 Market area: EU

Steril Spray Market area: EU PPP

IsoPure Market area: EU Flächendesin­ fektion ALK-DES Market area: EU

Laveo FDS Market area: EU Bäktec Market area: EU Flächendesin­ fektion Maschinen- Market area: EU und Flächendesin­ fektion PPP Brensolv K68 Market area: EU ISO 70 Market area: EU Authorisation number EU-0027707-0022 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 70 % (w/w) substance 26/34 ELI: http://data.europa.eu/eli/reg_impl/2026/1114/ojEN OJ L, 27.5.2026

7.3. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Budenat® Market area: EU Rapid Effect D 446 IPA 300 Market area: EU

Easydes IPA Market area: EU

Sonet Market area: EU

Isonet 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 Market area: EU Sanitized Strong

Alkosan Market area: EU Strong

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 67-63-0 200-661-7 63 % (w/w) substance

7.4. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Isopropa­ Market area: EU nol/Wasser 65/35% Authorisation number EU-0027707-0024 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 65 % (w/w) substance

ELI: http://data.europa.eu/eli/reg_impl/2026/1114/oj 27/34EN OJ L, 27.5.2026

7.5. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Curacid Food Market area: EU Rapid Dr. Desi Market area: EU Küchendesin­ fektion Authorisation number EU-0027707-0025 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 62,8 % (w/w) substance

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 Market area: EU Profumato Authorisation number EU-0027707-0026 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 63 % (w/w) substance

7.7. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Desmila HSI C Market area: EU

Vetasept Market area: EU Lemon Authorisation number EU-0027707-0027 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 63 % (w/w) substance 28/34 ELI: http://data.europa.eu/eli/reg_impl/2026/1114/ojEN OJ L, 27.5.2026

7.8. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Desmila HSI Market area: EU D

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 67-63-0 200-661-7 63 % (w/w) substance

7.9. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Desmila HSI P Market area: EU

Vetasept Market area: EU Pfirsich Authorisation number EU-0027707-0029 1-2 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 63 % (w/w) substance

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 67-63-0 200-661-7 64,7 % (w/w) substance

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

ELI: http://data.europa.eu/eli/reg_impl/2026/1114/oj 29/34EN OJ L, 27.5.2026

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 67-63-0 200-661-7 62,7 - 70 % (w/w) substance

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.

30/34 ELI: http://data.europa.eu/eli/reg_impl/2026/1114/ojEN OJ L, 27.5.2026

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 Not relevant authorised use Target organism(s) (including development Scientific name: Bacteria (incl. Mycobacteria), stage) 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.

ELI: http://data.europa.eu/eli/reg_impl/2026/1114/oj 31/34EN OJ L, 27.5.2026

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.

32/34 ELI: http://data.europa.eu/eli/reg_impl/2026/1114/ojEN OJ L, 27.5.2026

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

7.2. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Biogat H-Des Market area: EU

Isopropanol Market area: EU 70 biocide C

Isopropanol Market area: EU 70 C

IsoPure Market area: EU Händedesin­ fektion Authorisation number EU-0027707-0032 1-3 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 70 % (w/w) substance

ELI: http://data.europa.eu/eli/reg_impl/2026/1114/oj 33/34EN OJ L, 27.5.2026

7.3. Trade name(s), authorisation number and specific composition of each individual product Trade name(s) Rodalon Market area: EU Hand Sanitizer Authorisation number EU-0027707-0033 1-3 Common name IUPAC name Function CAS number EC number Content (%) Propan-2-ol Active 67-63-0 200-661-7 63 % (w/w) substance 34/34 ELI: http://data.europa.eu/eli/reg_impl/2026/1114/oj