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Document 32026R1114
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
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
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
C/2026/3273
OJ L, 2026/1114, , ELI: http://data.europa.eu/eli/reg_impl/2026/1114/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
|
Official Journal |
EN 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. |
|
(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
(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.
ANNEX
Summary of product characteristics for a biocidal product family
Brenntag GmbH Propan-2-ol Product Family
Product type(s)
PT01: Human hygiene
PT02: Disinfectants and algaecides not intended for direct application to humans or animals
PT04: Food and feed area
Authorisation number EU-0027707-0000
R4BP asset number EU-0027707-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1. Family name
|
Name |
Brenntag GmbH Propan-2-ol Product Family |
1.2. Product type(s)
|
Product type(s) |
PT01: Human hygiene PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area |
1.3. Authorisation holder
|
Name and address of the authorisation holder |
Name |
Brenntag GmbH |
|
Address |
Messeallee 11 45131 Essen DE |
|
|
Authorisation number |
|
EU-0027707-0000 |
|
R4BP asset number |
|
EU-0027707-0000 |
|
Date of the authorisation |
|
7.12.2022 |
|
Expiry date of the authorisation |
|
30.11.2032 |
1.4. Manufacturer(s) of the product
|
Name of manufacturer |
Kesla Pharma Wolfen GmbH |
|
Address of manufacturer |
Kesla-Str. 1 06803 Bitterfeld Germany |
|
Location of manufacturing sites |
Kesla Pharma Wolfen GmbH site 1 Kesla-Str. 1 06803 Bitterfeld Germany |
|
Name of manufacturer |
Buzil-Werk Wagner GmbH & Co. KG |
|
Address of manufacturer |
Fraunhoferstr. 17 87700 Memmingen Germany |
|
Location of manufacturing sites |
Buzil-Werk Wagner GmbH & Co. KG site 1 Fraunhoferstr. 17 87700 Memmingen Germany |
|
Name of manufacturer |
Wigol W. Stache GmbH |
|
Address of manufacturer |
Textorstr. 2 67547 Worms Germany |
|
Location of manufacturing sites |
Wigol W. Stache GmbH site 1 Textorstr. 2 67547 Worms Germany |
|
Name of manufacturer |
KiiltoClean Oy |
|
Address of manufacturer |
Tengströminkatu 6 FI-20630 Turku Finland |
|
Location of manufacturing sites |
KiiltoClean Oy site 1 PL 157 FI-20101 Turku Finland |
|
Name of manufacturer |
Witty GmbH und Co. KG |
|
Address of manufacturer |
Herrenrothstr. 12 86424 Dinkelscherben Germany |
|
Location of manufacturing sites |
Witty GmbH und Co. KG site 1 Herrenrothstr. 12 86424 Dinkelscherben Germany |
|
Name of manufacturer |
Carl Roth GmbH und Co. KG |
|
Address of manufacturer |
An der Mole 5 76189 Karlsruhe Germany |
|
Location of manufacturing sites |
Carl Roth GmbH und Co. KG site 1 An der Mole 5 76189 Karlsruhe Germany |
|
Name of manufacturer |
Anti-Germ International GmbH |
|
Address of manufacturer |
Oberbrühlstr. 16 87700 Memmingen Germany |
|
Location of manufacturing sites |
Anti-Germ International GmbH site 1 Oberbrühlstr. 16 87700 Memmingen Germany |
|
Name of manufacturer |
LCI FLOWEY |
|
Address of manufacturer |
2 ZAC Klengbusbierg 7795 Bissen Luxembourg |
|
Location of manufacturing sites |
LCI FLOWEY site 1 2 ZAC Klengbusbierg 7795 Bissen Luxembourg |
|
Name of manufacturer |
Hofmann & Sommer GmbH und Co. KG |
|
Address of manufacturer |
Lindenstr.11 07426 Königsee-Rottenbach Germany |
|
Location of manufacturing sites |
Hofmann & Sommer GmbH und Co. KG site 1 Lindenstr.11 07426 Königsee-Rottenbach Germany |
|
Name of manufacturer |
Girelli Alcool srl |
|
Address of manufacturer |
Via Thomas Edison 5 20080 Zibido San Giacomo (MI) Italy |
|
Location of manufacturing sites |
Girelli Alcool srl site 1 Via Thomas Edison 5 20080 Zibido San Giacomo (MI) Italy |
|
Name of manufacturer |
Brenntag S.p.A. |
|
Address of manufacturer |
Via Cusago 150/4 20158 Milano (MI) Italy |
|
Location of manufacturing sites |
Brenntag S.p.A. site 1 Via Cusago 150/4 20158 Milano (MI) Italy |
|
Name of manufacturer |
Brenntag SA |
|
Address of manufacturer |
90 Avenue du Progrès 69 680 Chassieu France |
|
Location of manufacturing sites |
Brenntag SA site 1 90 Avenue du Progrès 69 680 Chassieu France |
|
Name of manufacturer |
HYDRACHIM |
|
Address of manufacturer |
Z.A. ROUTE DE ST POIX 35370 LE PERTRE France |
|
Location of manufacturing sites |
HYDRACHIM site 1 Z.A. du piquet 35370 Etrelles France |
|
Name of manufacturer |
Langguth Chemie GmbH |
|
Address of manufacturer |
Wandalenstrasse 6 86343 Königsbrunn Germany |
|
Location of manufacturing sites |
Langguth Chemie GmbH site 1 Wandalenstrasse 6 86343 Königsbrunn Germany |
|
Name of manufacturer |
Burgess Galvin & Co |
|
Address of manufacturer |
Jamestown Road 11 Finglas, Dublin Ireland |
|
Location of manufacturing sites |
Burgess Galvin & Co site 1 Jamestown Road 11 Finglas, Dublin Ireland |
|
Name of manufacturer |
Brenntag Schweizerhall |
|
Address of manufacturer |
Elsässerstrasse 231 4056 Basel Switzerland |
|
Location of manufacturing sites |
Brenntag Schweizerhall site 1 Elsässerstrasse 231 4056 Basel Switzerland |
|
Name of manufacturer |
ORAPI |
|
Address of manufacturer |
5 Allee des Cerdes, Pi de la Plaine de L’ain 01150 Saint Vulbas France |
|
Location of manufacturing sites |
ORAPI site 1 5 Allee des Cerdes, Pi de la Plaine de L’ain 01150 Saint Vulbas France |
|
Name of manufacturer |
Copak S.A. |
|
Address of manufacturer |
Z.I. du Madrillet, rue de la Chênaie 76800 Saint-Etienne-du-Rouvray France |
|
Location of manufacturing sites |
Copak S.A. site 1 Z.I. du Madrillet, rue de la Chênaie 76800 Saint-Etienne-du-Rouvray France |
|
Name of manufacturer |
Water Technology Limited |
|
Address of manufacturer |
TOGHER INDUSTRIAL EST T12KPF2 CORK, DUBLIN Ireland |
|
Location of manufacturing sites |
Water Technology Limited site 1 TOGHER INDUSTRIAL EST T12KPF2 CORK, DUBLIN Ireland |
|
Name of manufacturer |
Otto Fischar GmbH & Co. KG |
|
Address of manufacturer |
Kaiserstr. 221 66133 Saarbruecken Germany |
|
Location of manufacturing sites |
Otto Fischar GmbH & Co. KG site 1 Kaiserstr. 221 66133 Saarbruecken Germany |
|
Name of manufacturer |
Caesar & Loretz GmbH |
|
Address of manufacturer |
Herderstr. 31 40721 Hilden Germany |
|
Location of manufacturing sites |
Caesar & Loretz GmbH site 1 Herderstr. 31 40721 Hilden Germany |
|
Name of manufacturer |
Karl-Josef Kost Alkohole & Produkte aus Alkohol KG |
|
Address of manufacturer |
Rauentalshöhe 4 56073 Koblenz Germany |
|
Location of manufacturing sites |
Karl-Josef Kost Alkohole & Produkte aus Alkohol KG site 1 Rauentalshöhe 4 56073 Koblenz Germany |
|
Name of manufacturer |
Höfer Chemie GmbH |
|
Address of manufacturer |
Zur Fabrik 2 66271 Kleinblittersdorf Germany |
|
Location of manufacturing sites |
Höfer Chemie GmbH site 1 Zur Fabrik 2 66271 Kleinblittersdorf Germany |
|
Name of manufacturer |
HWR-CHEMIE GmbH |
|
Address of manufacturer |
Moosfeldstraße 7 82275 Emmering Germany |
|
Location of manufacturing sites |
HWR-CHEMIE GmbH site 1 Moosfeldstraße 7 82275 Emmering Germany |
|
Name of manufacturer |
Renosan Chemie Technik GmbH |
|
Address of manufacturer |
Schützenstraße 5 98527 Suhl Germany |
|
Location of manufacturing sites |
Renosan Chemie Technik GmbH site 1 Schützenstraße 5 98527 Suhl Germany |
|
Name of manufacturer |
Gruppo LGM Srl |
|
Address of manufacturer |
Via Pola 32 20096 Pioltello (MI) Italy |
|
Location of manufacturing sites |
Gruppo LGM Srl site 1 Via Pola 32 20096 Pioltello (MI) Italy |
|
Name of manufacturer |
Brenntag Nordic A/S |
|
Address of manufacturer |
Høsten Teglværksvej 47 4690 Haslev Denmark |
|
Location of manufacturing sites |
Brenntag Nordic A/S site 1 Høsten Teglværksvej 47 4690 Haslev Denmark |
|
Name of manufacturer |
Brenntag GmbH |
|
Address of manufacturer |
Am Nordseekai 22 73207 Plochingen Germany |
|
Location of manufacturing sites |
Brenntag GmbH Am Nordseekai 22 73207 Plochingen Germany |
|
Name of manufacturer |
Brenntag GmbH |
|
Address of manufacturer |
Am Röhrenwerk 46 47259 Duisburg Germany |
|
Location of manufacturing sites |
Brenntag GmbH Am Röhrenwerk 46 47259 Duisburg Germany |
|
Name of manufacturer |
Brenntag GmbH |
|
Address of manufacturer |
Hannoversche Strasse 40 21079 Hamburg Germany |
|
Location of manufacturing sites |
Brenntag GmbH Hannoversche Strasse 40 21079 Hamburg Germany |
|
Name of manufacturer |
Hypred SAS - Kersia Group |
|
Address of manufacturer |
55 Boulevard Jules Verger, BP 10180 35803 Dinard Cedex France |
|
Location of manufacturing sites |
Hypred SAS - Kersia Group (Dinard site) 55 Boulevard Jules Verger, BP 10180 35803 Dinard Cedex France Hypred SAS - Kersia Group (Vaas site) Zone Industrielle Le Roineau 72500 Vaas France |
|
Name of manufacturer |
Medentech Ltd - Kersia Group |
|
Address of manufacturer |
Clonard Road Y35Y7WY Wexford Ireland |
|
Location of manufacturing sites |
Medentech Ltd - Kersia Group site 1 Clonard Road Y35Y7WY Wexford Ireland |
|
Name of manufacturer |
ACT Aerosol Chemie Technik GmbH |
|
Address of manufacturer |
Porschestrasse 7 73095 Albershausen Germany |
|
Location of manufacturing sites |
ACT Aerosol Chemie Technik GmbH site 1 Porschestrasse 7 73095 Albershausen Germany |
1.5. Manufacturer(s) of the active substance(s)
|
Active substance |
Propan-2-ol |
|
Name of manufacturer |
ExxonMobil |
|
Address of manufacturer |
4999 Scenic Highway LA 70897 Baton Rouge, Louisiana United States (the) |
|
Location of manufacturing sites |
ExxonMobil site 1 4999 Scenic Highway LA 70897 Baton Rouge, Louisiana United States (the) |
|
Active substance |
Propan-2-ol |
|
Name of manufacturer |
Shell Nederland Raffinaderij B.V. |
|
Address of manufacturer |
Vondelingenweg 601, Vodelingenenplaat 3196 KK Rotterdam Netherlands (the) |
|
Location of manufacturing sites |
Shell Nederland Raffinaderij B.V. site 1 Vondelingenweg 601, Vodelingenenplaat 3196 KK Rotterdam Netherlands (the) |
|
Active substance |
Propan-2-ol |
|
Name of manufacturer |
INEOS Solvents Germany GmbH |
|
Address of manufacturer |
Römerstrasse 733 47443 Moers Germany |
|
Location of manufacturing sites |
INEOS Solvents Germany GmbH site 1 Römerstrasse 733 47443 Moers Germany INEOS Solvents Germany GmbH site 2 Shamrockstraße 88 44623 Herne Germany |
2. PRODUCT FAMILY COMPOSITION AND FORMULATION
2.1. Qualitative and quantitative information on the composition of the family
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Propan-2-ol |
|
Active substance |
67-63-0 |
200-661-7 |
62,7 - 70 % (w/w) |
2.2. Type(s) of formulation
|
Formulation type(s) |
Meta SPC 1: CL - Contact gel or Liquid Meta SPC 2: XX – Others: Ready-to-Use trigger spray Meta SPC 3: CL - Contact gel or Liquid |
PART II
SECOND INFORMATION LEVEL META SPC(S)
1. META SPC 1 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 1 identifier
|
Identifier |
Meta SPC: Meta SPC 1 |
1.2. Suffix to the authorisation number
|
Number |
1-1 |
1.3. Product type(s)
|
Product type(s) |
PT01: Human hygiene |
2. META SPC 1 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 1
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Propan-2-ol |
|
Active substance |
67-63-0 |
200-661-7 |
62,7 - 70 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 1
|
Formulation type(s) |
Meta SPC 1: CL - Contact gel or Liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
|
Hazard statements |
H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. |
|
Precautionary statements |
P101: If medical advice is needed, have product container or label at hand. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P261: Avoid breathing vapours. P261: Avoid breathing spray. P271: Use only outdoors or in a well-ventilated area. P280: Wear eye protection. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER/ doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical advice. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local regulations. P501: Dispose of container in accordance with local regulations. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use 1 – Contact Gel or Liquid - Hygienic handrub - Professional user
|
Product type |
PT01: Human hygiene |
||||||||
|
Where relevant, an exact description of the authorised use |
Not relevant |
||||||||
|
Target organism(s) (including development stage) |
Scientific name: Bacteria (incl. Mycobacteria), Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: Enveloped viruses Common name: - Development stage: - |
||||||||
|
Field(s) of use |
indoor use For professional use only. For use in private, public, healthcare and industrial areas and in areas for professional activities. |
||||||||
|
Application method(s) |
Method: Direct application to both hands, rubbing Detailed description: - |
||||||||
|
Application rate(s) and frequency |
Application Rate: 3 ml applied to one hand and complete surface of both hands are moistened and rubbed for 60 seconds per application. - Number and timing of application: Up to 25 disinfections per day, 5 day(s) per week |
||||||||
|
Category(ies) of users |
professional |
||||||||
|
Pack sizes and packaging material |
|
4.1.1. Use-specific instructions for use
See general directions for use.
4.1.2. Use-specific risk mitigation measures
See general directions for use.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1
5.1. Instructions for use
|
1) |
For professional use only. |
|
2) |
Products must be shaken before use. |
|
3) |
Only apply on dry and visibly clean hands. |
|
4) |
For hand disinfection a ready-to-use gel or liquid (3 ml) is poured into the palms of one hand and the complete surface of both hands are moistened and rubbed for 60 seconds per application. |
5.2. Risk mitigation measures
|
1) |
Avoid contact with eyes. |
|
2) |
Keep out of reach of children and pets. |
|
3) |
Use only in well-ventilated areas. |
|
4) |
For refilling a funnel must be applied. |
|
5) |
The following personal risk mitigation measure can be considered for refilling procedure unless it can be replaced by technical and / or organisational measures:
The use of eye protection during refilling of the product is recommended. |
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
|
1) |
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. |
|
2) |
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. |
5.4. Instructions for safe disposal of the product and its packaging
|
1) |
Product: Disposal together with normal waste is not allowed. Special disposal required according to local regulations. |
|
2) |
Do not let product enter drains. |
|
3) |
Contact waste disposal services. |
|
4) |
Contaminated packaging: Empty contaminated packaging thoroughly. They can be recycled after thorough and proper cleaning. Packaging that cannot be cleaned are to be disposed of in the same manner as the product. |
|
5) |
Do not burn, or use a cutting torch on, the empty drum. Risk of explosion. |
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
|
1) |
Store in a well-ventilated place. |
|
2) |
Keep cool. |
|
3) |
Keep container tightly closed. |
|
4) |
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. |
|
5) |
Shelf-life: 24 months |
6. OTHER INFORMATION
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
7.1. Trade name(s), authorisation number and specific composition of each individual product
|
Trade name(s) |
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 % (w/w) |
||
7.2. Trade name(s), authorisation number and specific composition of each individual product
|
Trade name(s) |
Budenat® Protect Hand D807 |
Market area: EU |
|||||
|
Rodalon Hand Sanitizer |
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 % (w/w) |
||
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 |
||||||
|
HÄNDE-DES fluid |
Market area: EU |
||||||
|
Laveo HD |
Market area: EU |
||||||
|
Bäktec Händedesinfektion |
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 % (w/w) |
||
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 % (w/w) |
||
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 % (w/w) |
||
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 % (w/w) |
||
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 % (w/w) |
||
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 % (w/w) |
||
7.9. Trade name(s), authorisation number and specific composition of each individual product
|
Trade name(s) |
HD18 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 % (w/w) |
||
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 % (w/w) |
||
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 % (w/w) |
||
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 % (w/w) |
||
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 % (w/w) |
||
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 % (w/w) |
||
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 % (w/w) |
||
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 |
||||||
|
Sinco ManoSept |
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 % (w/w) |
||
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 % (w/w) |
||
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 % (w/w) |
||
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 % (w/w) |
||
7.20. Trade name(s), authorisation number and specific composition of each individual product
|
Trade name(s) |
Desmila LSI pure |
Market area: EU |
|||||
|
Mobilomed Skinsoft Sensitiv |
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 % (w/w) |
||
1. META SPC 2 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 2 identifier
|
Identifier |
Meta SPC: Meta SPC 2 |
1.2. Suffix to the authorisation number
|
Number |
1-2 |
1.3. Product type(s)
|
Product type(s) |
PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area |
2. META SPC 2 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 2
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Propan-2-ol |
|
Active substance |
67-63-0 |
200-661-7 |
62,8 - 70 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 2
|
Formulation type(s) |
Meta SPC 2: XX – Others: Ready-to-Use trigger spray |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
|
Hazard statements |
H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. |
|
Precautionary statements |
P101: If medical advice is needed, have product container or label at hand. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P261: Avoid breathing vapours. P261: Avoid breathing spray. P271: Use only outdoors or in a well-ventilated area. P280: Wear eye protection. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER/doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical advice. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local regulations. P501: Dispose of container in accordance with local regulations. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use 1 – Liquid Spray – Small surface disinfection – Professional user
|
Product type |
PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
||||||||
|
Where relevant, an exact description of the authorised use |
Not relevant. |
||||||||
|
Target organism(s) (including development stage) |
Scientific name: Bacteria (incl. Mycobacteria), Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - |
||||||||
|
Field(s) of use |
indoor use Disinfection of small non-porous surfaces, materials, equipment and furniture in private, public, healthcare, industrial areas and in areas for professional activities. |
||||||||
|
Application method(s) |
Method: spraying Detailed description: - |
||||||||
|
Application rate(s) and frequency |
Application Rate: For surface disinfection a ready-to-use spray solution (20 ml/m2) is applied on surfaces at room temperature. - Number and timing of application: Application according to requirements, one application per use, 4 times per day. Small surface disinfection(other than healthcare): Bactericidal and yeasticidal: contact time at least 1 min In healthcare area: Bactericidal and yeasticidal: contact time at least 5 min |
||||||||
|
Category(ies) of users |
professional |
||||||||
|
Pack sizes and packaging material |
|
4.1.1. Use-specific instructions for use
|
1) |
Apply the ready-to-use product to the surface by spraying. Make sure to wet surfaces completely and wait for 1 minute (general surface disinfection) or 5 minutes (surfaces in healthcare area ) |
|
2) |
For use at room temperature. |
|
3) |
Application according to requirements, one application per use, 4 times per day. |
4.1.2. Use-specific risk mitigation measures
The following personal risk mitigation measure can be considered for refilling procedure unless it can be replaced by technical and / or organisational measures:
The use of eye protection during refilling of the product is recommended.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.2. Use description
Table 2
Use 2 – Liquid Spray - Disinfection for small food contact surfaces – Professional user
|
Product type |
PT04: Food and feed area |
||||||||
|
Where relevant, an exact description of the authorised use |
Not relevant |
||||||||
|
Target organism(s) (including development stage) |
Scientific name: Bacteria Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - |
||||||||
|
Field(s) of use |
indoor use Disinfection of small non-porous surfaces in food sector or food processing industries (including breweries, dairy industry and meat industry). |
||||||||
|
Application method(s) |
Method: spraying Detailed description: - |
||||||||
|
Application rate(s) and frequency |
Application Rate: For surface disinfection a ready-to-use spray solution (20 ml/m2) is applied on surfaces at room temperature. - Number and timing of application: Application according to requirements, one application per use, 4 times per day. Small surface disinfection: Bactericidal and yeasticidal: contact time at least 1 min In Breweries/ meat industry: Bactericidal and yeasticidal: contact time at least 5 min In dairy industry: Bactericidal and yeasticidal: contact time at least 15 min |
||||||||
|
Category(ies) of users |
professional |
||||||||
|
Pack sizes and packaging material |
|
4.2.1. Use-specific instructions for use
|
1) |
Apply the ready-to-use product to the surface by spraying. Make sure to wet surfaces completely and wait for at least 1 min (general surface disinfection), 5 min (surface disinfection in breweries or meat industry) or at least 15 min (surface disinfection in dairy industry). |
|
2) |
For use at room temperature. |
|
3) |
Application according to requirements, one application per use, 4 times per day. |
4.2.2. Use-specific risk mitigation measures
The following personal risk mitigation measure can be considered for disinfection of food processing machinery and refilling procedure unless it can be replaced by technical and / or organisational measures: The use of eye protection during handling of the product is recommended.
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2
5.1. Instructions for use
|
1) |
Products must be shaken before use. |
|
2) |
Do not apply more than 20 mL/m2. |
|
3) |
Used wipes must be disposed in a closed container. |
5.2. Risk mitigation measures
|
1) |
Avoid contact with eyes. |
|
2) |
For refilling a funnel must be applied. |
|
3) |
The product must only be applied for disinfection of small surfaces. |
|
4) |
Keep out of reach of children and pets. |
|
5) |
Use only in well-ventilated areas. |
|
6) |
Keep children and pets away from rooms where disinfection is taking place. |
|
7) |
Provide adequate ventilation before children and pets enter treated rooms. |
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
|
1) |
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor. |
|
2) |
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. |
5.4. Instructions for safe disposal of the product and its packaging
|
1) |
Product: Disposal together with normal waste is not allowed. Special disposal required according to local regulations. |
|
2) |
Do not let product enter drains. |
|
3) |
Contact waste disposal services. |
|
4) |
Contaminated packaging: Empty contaminated packaging thoroughly. They can be recycled after thorough and proper cleaning. Packaging that cannot be cleaned are to be disposed of in the same manner as the product. |
|
5) |
Do not burn, or use a cutting torch on, the empty drum. Risk of explosion. |
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
|
1) |
Store in a well-ventilated place. |
|
2) |
Keep cool. |
|
3) |
Keep container tightly closed. |
|
4) |
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. |
|
5) |
Shelf-life: 24 months |
6. OTHER INFORMATION
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
7.1. Trade name(s), authorisation number and specific composition of each individual product
|
Trade name(s) |
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 |
||||||
|
HD 10 Fast Germs |
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 % (w/w) |
||
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 |
||||||
|
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 |
||||||
|
IsoPure Flächendesinfektion |
Market area: EU |
||||||
|
ALK-DES |
Market area: EU |
||||||
|
Laveo FDS |
Market area: EU |
||||||
|
Bäktec Flächendesinfektion |
Market area: EU |
||||||
|
Maschinen- und Flächendesinfektion PPP |
Market area: EU |
||||||
|
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 substance |
67-63-0 |
200-661-7 |
70 % (w/w) |
||
7.3. Trade name(s), authorisation number and specific composition of each individual product
|
Trade name(s) |
Budenat® Rapid Effect D 446 |
Market area: EU |
|||||
|
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 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 % (w/w) |
||
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 % (w/w) |
||
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 % (w/w) |
||
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 % (w/w) |
||
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 % (w/w) |
||
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 % (w/w) |
||
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 % (w/w) |
||
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 % (w/w) |
||
1. META SPC 3 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 3 identifier
|
Identifier |
Meta SPC: Meta SPC 3 |
1.2. Suffix to the authorisation number
|
Number |
1-3 |
1.3. Product type(s)
|
Product type(s) |
PT01: Human hygiene |
2. META SPC 3 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 3
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Propan-2-ol |
|
Active substance |
67-63-0 |
200-661-7 |
62,7 - 70 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 3
|
Formulation type(s) |
Meta SPC 3: CL - Contact gel or Liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
|
Hazard statements |
H225: Highly flammable liquid and vapour. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. EUH066: Repeated exposure may cause skin dryness or cracking. |
|
Precautionary statements |
P101: If medical advice is needed, have product container or label at hand. P102: Keep out of reach of children. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P261: Avoid breathing vapours. P261: Avoid breathing spray. P271: Use only outdoors or in a well-ventilated area. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312: Call a POISON CENTER/doctor if you feel unwell. P337+P313: If eye irritation persists: Get medical advice. P403+P235: Store in a well-ventilated place. Keep cool. P405: Store locked up. P501: Dispose of contents in accordance with local regulations. P501: Dispose of container in accordance with local regulations. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Use 1 – Contact Gel or Liquid - Hygienic handrub - Non-professional user
|
Product type |
PT01: Human hygiene |
|
Where relevant, an exact description of the authorised use |
Not relevant |
|
Target organism(s) (including development stage) |
Scientific name: Bacteria (incl. Mycobacteria), Common name: - Development stage: - Scientific name: Yeast Common name: - Development stage: - Scientific name: Enveloped viruses Common name: - Development stage: - |
|
Field(s) of use |
indoor use For use in private and public areas. |
|
Application method(s) |
Method: Direct application to both hands, rubbing Detailed description: - |
|
Application rate(s) and frequency |
Application Rate: 3 ml applied to one hand and complete surface of both hands are moistened and rubbed for 60 seconds per application. - Number and timing of application: Up to 5 disinfections per day, 5 day(s) per week |
|
Category(ies) of users |
general public (non-professional) |
|
Pack sizes and packaging material |
Bottle HD-PE: 0,1L - 1,0L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP)) |
4.1.1. Use-specific instructions for use
See general directions for use.
4.1.2. Use-specific risk mitigation measures
See general directions for use.
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 3
5.1. Instructions for use
|
1) |
Comply with the instructions for use. |
|
2) |
Products must be shaken before use. |
|
3) |
Only apply on dry and visibly clean hands. |
|
4) |
For hand disinfection a ready-to-use gel or liquid (3 ml) is poured into the palms of one hand and the complete surface of both hands are moistened and rubbed for 60 seconds per application. |
|
5) |
The authorisation holder has to specify the typical application rate in a simple, easily understandable form on the label:
|
5.2. Risk mitigation measures
|
1) |
Avoid contact with eyes. |
|
2) |
Use by children only under supervision of an adult. |
|
3) |
Use only in well-ventilated areas. |
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
|
1) |
If medical advice is needed, have product container or label at hand. |
|
2) |
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing for five minutes. |
|
3) |
Call a POISON CENTER or doctor if you feel unwell. |
|
4) |
If eye irritation persists: Get medical advice/attention. |
|
5) |
IF INHALED OR SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor. |
5.4. Instructions for safe disposal of the product and its packaging
|
1) |
Product: Disposal together with normal waste is not allowed. Special disposal required according to local regulations. |
|
2) |
Do not let product enter drains. |
|
3) |
Contact waste disposal services. |
|
4) |
Contaminated packaging: Empty contaminated packaging thoroughly. They can be recycled after thorough and proper cleaning. Packaging that cannot be cleaned are to be disposed of in the same manner as the product. |
|
5) |
Do not burn, or use a cutting torch on, the empty drum. Risk of explosion. |
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
|
1) |
Store in a well-ventilated place. |
|
2) |
Keep cool. |
|
3) |
Keep container tightly closed. |
|
4) |
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. |
|
5) |
Keep out of reach of children and pets. |
|
6) |
Shelf-life: 24 months |
6. OTHER INFORMATION
-
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
7.1. Trade name(s), authorisation number and specific composition of each individual product
|
Trade name(s) |
Frend Hand Sanitiser Gel |
Market area: EU |
|||||
|
Authorisation number |
|
EU-0027707-0031 1-3 |
|||||
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
||
|
Propan-2-ol |
|
Active substance |
67-63-0 |
200-661-7 |
65,3 % (w/w) |
||
7.2. Trade name(s), authorisation number and specific composition of each individual product
|
Trade name(s) |
Biogat H-Des |
Market area: EU |
|||||
|
Isopropanol 70 biocide C |
Market area: EU |
||||||
|
Isopropanol 70 C |
Market area: EU |
||||||
|
IsoPure Händedesinfektion |
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 % (w/w) |
||
7.3. Trade name(s), authorisation number and specific composition of each individual product
|
Trade name(s) |
Rodalon Hand Sanitizer |
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 % (w/w) |
||
ELI: http://data.europa.eu/eli/reg_impl/2026/1114/oj
ISSN 1977-0677 (electronic edition)