# L_2022297EN.01000101.xml

| 17.11.2022 | EN | Official Journal of the European Union | L 297/1 |
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17.11.2022

EN

Official Journal of the European Union

L 297/1

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COMMISSION IMPLEMENTING REGULATION (EU) 2022/2252

of 11 November 2022

granting a Union authorisation for the biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the Article 44(5), first subparagraph, thereof,

Whereas:

| (1) | On 30 June 2016, Brenntag GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Brenntag GmbH Propan-2-ol Product Family’ of product-types 1, 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Germany had agreed to evaluate the application. The application was recorded under case number BC-BL025673-43 in the Register for Biocidal Products. |
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(1)

On 30 June 2016, Brenntag GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Brenntag GmbH Propan-2-ol Product Family’ of product-types 1, 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Germany had agreed to evaluate the application. The application was recorded under case number BC-BL025673-43 in the Register for Biocidal Products.

| (2) | ‘Brenntag GmbH Propan-2-ol Product Family’ contains propan-2-ol as the active substance, which is included in the Union list of approved active substance referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 1, 2 and 4. |
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(2)

‘Brenntag GmbH Propan-2-ol Product Family’ contains propan-2-ol as the active substance, which is included in the Union list of approved active substance referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 1, 2 and 4.

| (3) | On 15 March 2021, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’). |
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(3)

On 15 March 2021, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

| (4) | On 4 November 2021, the Agency submitted to the Commission an opinion (2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘Brenntag GmbH Propan-2-ol Product Family’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. |
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(4)

On 4 November 2021, the Agency submitted to the Commission an opinion (2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘Brenntag GmbH Propan-2-ol Product Family’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.

| (5) | The opinion concludes that ‘Brenntag GmbH Propan-2-ol Product Family’ is a ‘biocidal product family’ within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation. |
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(5)

The opinion concludes that ‘Brenntag GmbH Propan-2-ol Product Family’ is a ‘biocidal product family’ within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

| (6) | On 22 November 2021, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. |
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(6)

On 22 November 2021, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

| (7) | The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Brenntag GmbH Propan-2-ol Product Family’. |
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(7)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Brenntag GmbH Propan-2-ol Product Family’.

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on biocidal products, |
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(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on biocidal products,

HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0027707-0000 is granted to Brenntag GmbH for the making available on the market and use of the biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union Authorisation is valid from 7 December 2022 to 30 November 2032.

Article 2

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

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

Done at Brussels, 11 November 2022.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 167, 27.6.2012, p. 1.

1

(2)  ECHA opinion of 7 October 2021 on the Union authorisation of ‘Brenntag GmbH Propan-2-ol Product Family’ (ECHA/BPC/290/2021), https://echa.europa.eu/bpc-opinions-on-union-authorisation

2

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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 |
| --- | --- |

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) |
| --- | --- |

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 |

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 |

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

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

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 |

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 |

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 |
| --- | --- |

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 |
| --- | --- |

Identifier

Meta SPC 1

1.2.   Suffix to the authorisation number

| Number | 1-1 |
| --- | --- |

Number

1-1

1.3.   Product type(s)

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

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 |

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 |
| --- | --- |

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. |

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)) |

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) |
| --- | --- |

—

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)) |
| --- | --- |

—

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) |
| --- | --- |

—

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. |
| --- | --- |

1)

For professional use only.

| 2) | Products must be shaken before use. |
| --- | --- |

2)

Products must be shaken before use.

| 3) | Only apply on dry and visibly clean hands. |
| --- | --- |

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. |
| --- | --- |

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. |
| --- | --- |

1)

Avoid contact with eyes.

| 2) | Keep out of reach of children and pets. |
| --- | --- |

2)

Keep out of reach of children and pets.

| 3) | Use only in well-ventilated areas. |
| --- | --- |

3)

Use only in well-ventilated areas.

| 4) | For refilling a funnel must be applied. |
| --- | --- |

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: |
| --- | --- |

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. |
| --- | --- |

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. |
| --- | --- |

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. |
| --- | --- |

1)

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

| 2) | Do not let product enter drains. |
| --- | --- |

2)

Do not let product enter drains.

| 3) | Contact waste disposal services. |
| --- | --- |

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. |
| --- | --- |

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)

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. |
| --- | --- |

1)

Store in a well-ventilated place.

| 2) | Keep cool. |
| --- | --- |

2)

Keep cool.

| 3) | Keep container tightly closed. |
| --- | --- |

3)

Keep container tightly closed.

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

4)

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

| 5) | Shelf-life: 24 months |
| --- | --- |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |
| --- | --- |

Identifier

Meta SPC 2

1.2.   Suffix to the authorisation number

| Number | 1-2 |
| --- | --- |

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) |
| --- | --- |

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 |

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 |
| --- | --- |

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. |

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. |

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 |
| --- | --- |

Bactericidal and yeasticidal: contact time at least 1 min

In healthcare area:

| | Bactericidal and yeasticidal: contact time at least 5 min |
| --- | --- |

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)) |
| --- | --- |

—

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) |
| --- | --- |

—

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)) |
| --- | --- |

—

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) |
| --- | --- |

—

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) |
| --- | --- |

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. |
| --- | --- |

2)

For use at room temperature.

| 3) | Application according to requirements, one application per use, 4 times per day. |
| --- | --- |

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. |

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 |
| --- | --- |

Bactericidal and yeasticidal: contact time at least 1 min

In Breweries/meat industry:

| | Bactericidal and yeasticidal: contact time at least 5 min |
| --- | --- |

Bactericidal and yeasticidal: contact time at least 5 min

In dairy industry:

| | Bactericidal and yeasticidal: contact time at least 15 min |
| --- | --- |

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)) |
| --- | --- |

—

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) |
| --- | --- |

—

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)) |
| --- | --- |

—

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) |
| --- | --- |

—

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). |
| --- | --- |

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. |
| --- | --- |

2)

For use at room temperature.

| 3) | Application according to requirements, one application per use, 4 times per day. |
| --- | --- |

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. |
| --- | --- |

1)

Products must be shaken before use.

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

2)

Do not apply more than 20 mL/m2.

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

3)

Used wipes must be disposed in a closed container.

5.2.   Risk mitigation measures

| 1) | Avoid contact with eyes. |
| --- | --- |

1)

Avoid contact with eyes.

| 2) | For refilling a funnel must be applied. |
| --- | --- |

2)

For refilling a funnel must be applied.

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

3)

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

| 4) | Keep out of reach of children and pets. |
| --- | --- |

4)

Keep out of reach of children and pets.

| 5) | Use only in well-ventilated areas. |
| --- | --- |

5)

Use only in well-ventilated areas.

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

6)

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

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

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. |
| --- | --- |

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. |
| --- | --- |

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. |
| --- | --- |

1)

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

| 2) | Do not let product enter drains. |
| --- | --- |

2)

Do not let product enter drains.

| 3) | Contact waste disposal services. |
| --- | --- |

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. |
| --- | --- |

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)

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. |
| --- | --- |

1)

Store in a well-ventilated place.

| 2) | Keep cool. |
| --- | --- |

2)

Keep cool.

| 3) | Keep container tightly closed. |
| --- | --- |

3)

Keep container tightly closed.

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

4)

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

| 5) | Shelf-life: 24 months |
| --- | --- |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |
| --- | --- |

Identifier

Meta SPC 3

1.2.   Suffix to the authorisation number

| Number | 1-3 |
| --- | --- |

Number

1-3

1.3.   Product type(s)

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

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 |

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 |
| --- | --- |

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. |

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)) |

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. |
| --- | --- |

1)

Comply with the instructions for use.

| 2) | Products must be shaken before use. |
| --- | --- |

2)

Products must be shaken before use.

| 3) | Only apply on dry and visibly clean hands. |
| --- | --- |

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. |
| --- | --- |

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) |
| --- | --- | --- |

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 |
| --- | --- |

—

Pump spray: Apply 3 pump strokes

| — | Bottle: Visual observation |
| --- | --- |

—

Bottle: Visual observation

5.2.   Risk mitigation measures

| 1) | Avoid contact with eyes. |
| --- | --- |

1)

Avoid contact with eyes.

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

2)

Use by children only under supervision of an adult.

| 3) | Use only in well-ventilated areas. |
| --- | --- |

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. |
| --- | --- |

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. |
| --- | --- |

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. |
| --- | --- |

3)

Call a POISON CENTER or doctor if you feel unwell.

| 4) | If eye irritation persists: Get medical advice/attention. |
| --- | --- |

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)

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. |
| --- | --- |

1)

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

| 2) | Do not let product enter drains. |
| --- | --- |

2)

Do not let product enter drains.

| 3) | Contact waste disposal services. |
| --- | --- |

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. |
| --- | --- |

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)

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. |
| --- | --- |

1)

Store in a well-ventilated place.

| 2) | Keep cool. |
| --- | --- |

2)

Keep cool.

| 3) | Keep container tightly closed. |
| --- | --- |

3)

Keep container tightly closed.

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

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. |
| --- | --- |

5)

Keep out of reach of children and pets.

| 6) | Shelf-life: 24 months |
| --- | --- |

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 |

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 |

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 |

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.

---