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)

ANNEX
ANNEX
Summary of product characteristics for a biocidal product family
Brenntag GmbH Propan-2-ol Product Family
Product type 1 – Human hygiene (Disinfectants)
Product type 4 – Food and feed area (Disinfectants)
Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Authorisation number: EU-0027707-0000
R4BP asset number: EU-0027707-0000
PART I
FIRST INFORMATION LEVEL
1.   ADMINISTRATIVE INFORMATION
1.1.    Family name
Name
Brenntag GmbH Propan-2-ol Product Family
1.2.    Product type(s)
Product type(s)
PT01 – Human hygiene (Disinfectants)
PT04 – Food and feed area (Disinfectants)
PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
1.3.    Authorisation holder
Name and address of the authorisation holder
Name
Brenntag GmbH
Address
Messeallee 11, 45131 Essen Germany
Authorisation number
EU-0027707-0000
R4BP asset number
EU-0027707-0000
Date of the authorisation
7 December 2022
Expiry date of the authorisation
30 November 2032
1.4.    Manufacturer(s) of the biocidal products
Name of manufacturer
Kesla Pharma Wolfen GmbH
Address of manufacturer
Kesla-Str. 1, 06803 Bitterfeld Germany
Location of manufacturing sites
Kesla-Str. 1, 06803 Bitterfeld Germany
Name of manufacturer
Dreve GmbH
Address of manufacturer
Max-Planck-Str. 31, 59423 Unna Germany
Location of manufacturing sites
Kesla Pharma Wolfen GmbH, Kesla-Str. 1, 06803 Bitterfeld Germany
Name of manufacturer
Buzil-Werk Wagner GmbH & Co. KG
Address of manufacturer
Fraunhoferstr. 17, 87700 Memmingen Germany
Location of manufacturing sites
Fraunhoferstr. 17, 87700 Memmingen Germany
Name of manufacturer
Wigol W. Stache GmbH
Address of manufacturer
Textorstr. 2, 67547 Worms Germany
Location of manufacturing sites
Textorstr. 2, 67547 Worms Germany
Name of manufacturer
KiiltoClean Oy
Address of manufacturer
Tengströminkatu 6, FI-20630 Turku Finland
Location of manufacturing sites
PL 157, FI-20101 Turku Finland
Name of manufacturer
Witty GmbH und Co. KG
Address of manufacturer
Herrenrothstr. 12, 86424 Dinkelscherben Germany
Location of manufacturing sites
Herrenrothstr. 12, 86424 Dinkelscherben Germany
Name of manufacturer
Carl Roth GmbH und Co. KG
Address of manufacturer
An der Mole 5, 76189 Karlsruhe Germany
Location of manufacturing sites
An der Mole 5, 76189 Karlsruhe Germany
Name of manufacturer
Pro-cura Hy-med GmbH
Address of manufacturer
Stresemannstrasse 364, 22761 Hamburg Germany
Location of manufacturing sites
A.F.P., Otto-Brenner-Str. 16, 21337 Lüneburg Germany
Name of manufacturer
Pico-medical GmbH
Address of manufacturer
Fangdieckstr. 24, 22547 Hamburg Germany
Location of manufacturing sites
A.F.P., Otto-Brenner-Str. 16, 21337 Lüneburg Germany
Name of manufacturer
Anti-Germ International GmbH
Address of manufacturer
Oberbrühlstr. 16, 87700 Memmingen Germany
Location of manufacturing sites
Oberbrühlstr. 16, 87700 Memmingen Germany
Name of manufacturer
LCI FLOWEY
Address of manufacturer
2 ZAC Klengbusbierg, 7795 Bissen Luxembourg
Location of manufacturing sites
2 ZAC Klengbusbierg, 7795 Bissen Luxembourg
Name of manufacturer
Hofmann & Sommer GmbH und Co. KG
Address of manufacturer
Lindenstr.11, 07426 Königsee-Rottenbach Germany
Location of manufacturing sites
Lindenstr.11, 07426 Königsee-Rottenbach Germany
Name of manufacturer
Girelli Alcool srl
Address of manufacturer
Via Thomas Edison 5, 20080 Zibido San Giacomo (MI) Italy
Location of manufacturing sites
Via Thomas Edison 5, 20080 Zibido San Giacomo (MI) Italy
Name of manufacturer
Brenntag S.p.A.
Address of manufacturer
Via Cusago 150/4, 20158 Milano (MI) Italy
Location of manufacturing sites
Via Cusago 150/4, 20158 Milano (MI) Italy
Name of manufacturer
I.C.F. Srl
Address of manufacturer
Via G.B. Benzoni 50, 26020 Palazzo Pignano (CR) Italy
Location of manufacturing sites
Via G.B. Benzoni 50, 26020 Palazzo Pignano (CR) Italy
Name of manufacturer
Brenntag SA
Address of manufacturer
90 Avenue du Progrès, 69 680 Chassieu France
Location of manufacturing sites
90 Avenue du Progrès, 69 680 Chassieu France
Name of manufacturer
Brenntag GmbH
Address of manufacturer
Stinnes-Platz 1, 45472 Muelheim a.d. Ruhr Germany
Location of manufacturing sites
Stinnes-Platz 1, 45472 Muelheim a.d. Ruhr Germany
Name of manufacturer
BCD Chemie GmbH
Address of manufacturer
Schellerdamm 16, 21079 Hamburg Germany
Location of manufacturing sites
Schellerdamm 16, 21079 Hamburg Germany
Name of manufacturer
HYDRACHIM
Address of manufacturer
Z.A. ROUTE DE ST POIX, 35370 LE PERTRE France
Location of manufacturing sites
Z.A. du piquet, 35370 Etrelles France
Name of manufacturer
Langguth Chemie GmbH
Address of manufacturer
Wandalenstrasse 6, 86343 Königsbrunn Germany
Location of manufacturing sites
Wandalenstrasse 6, 86343 Königsbrunn Germany
Name of manufacturer
Burgess Galvin & Co
Address of manufacturer
Jamestown Road, 11 Finglas, Dublin Ireland
Location of manufacturing sites
Jamestown Road, 11 Finglas, Dublin Ireland
Name of manufacturer
Tristel
Address of manufacturer
Lynx Business Park, Fordham Road, CB8 7NY Snailwell, Cambridge United Kingdom
Location of manufacturing sites
Lynx Business Park, Fordham Road, CB8 7NY Snailwell, Cambridge United Kingdom
Name of manufacturer
Brenntag Schweizerhall
Address of manufacturer
Elsässerstrasse 231, 4056 Basel Switzerland
Location of manufacturing sites
Elsässerstrasse 231, 4056 Basel Switzerland
Name of manufacturer
ORAPI
Address of manufacturer
5 Allee des Cerdes, Pi de la Plaine de L’ain, 01150 Saint Vulbas France
Location of manufacturing sites
5 Allee des Cerdes, Pi de la Plaine de L’ain, 01150 Saint Vulbas France
Name of manufacturer
Copak S.A.
Address of manufacturer
Z.I. du Madrillet, rue de la Chênaie, 76800 Saint-Etienne-du-Rouvray France
Location of manufacturing sites
Z.I. du Madrillet, rue de la Chênaie, 76800 Saint-Etienne-du-Rouvray France
Name of manufacturer
Water Technology Limited
Address of manufacturer
TOGHER INDUSTRIAL EST, T12KPF2 CORK, DUBLIN Ireland
Location of manufacturing sites
TOGHER INDUSTRIAL EST, T12KPF2 CORK, DUBLIN Ireland
Name of manufacturer
AF International, Electrolube: Divisions of H K Wentworth Ltd
Address of manufacturer
AASHBY PARK, COALFIELD WAY, ASHBY DE LA ZOUCH, LE65 1JF LEICESTERSHIRE United Kingdom
Location of manufacturing sites
AASHBY PARK, COALFIELD WAY, ASHBY DE LA ZOUCH, LE65 1JF LEICESTERSHIRE United Kingdom
Name of manufacturer
Bello Mondo bvba
Address of manufacturer
Helststraat 150-159, 2630 Aartselaar Belgium
Location of manufacturing sites
Laboratoria Smeets N.V., Fotografielaan 42, B-2610 Antwerpen-Wilrijk Belgium
Name of manufacturer
CERICHEM BIOPHARM SRL
Address of manufacturer
Viale Einaudi snc (z.i.), 71042 Cerignola (FG) Italy
Location of manufacturing sites
Viale Einaudi snc (z.i.), 71042 Cerignola (FG) Italy
Name of manufacturer
Otto Fischar GmbH & Co. KG
Address of manufacturer
Kaiserstr. 221, 66133 Saarbruecken Germany
Location of manufacturing sites
Kaiserstr. 221, 66133 Saarbruecken Germany
Name of manufacturer
Caesar & Loretz GmbH
Address of manufacturer
Herderstr. 31, 40721 Hilden Germany
Location of manufacturing sites
Herderstr. 31, 40721 Hilden Germany
Name of manufacturer
Karl-Josef Kost Alkohole & Produkte aus Alkohol KG
Address of manufacturer
Rauentalshöhe 4, 56073 Koblenz Germany
Location of manufacturing sites
Rauentalshöhe 4, 56073 Koblenz Germany
1.5.    Manufacturer(s) of the active substance(s)
Active substance
Propan-2-ol
Name of manufacturer
ExxonMobil
Address of manufacturer
4999 Scenic Highway, LA 70897 Baton Rouge, Louisiana United States
Location of manufacturing sites
4999 Scenic Highway, LA 70897 Baton Rouge, Louisiana United States
Active substance
Propan-2-ol
Name of manufacturer
Shell Nederland Raffinaderij B.V.
Address of manufacturer
Vondelingenweg 601, Vodelingenenplaat, 3196 KK Rotterdam Netherlands
Location of manufacturing sites
Vondelingenweg 601, Vodelingenenplaat, 3196 KK Rotterdam Netherlands
Active substance
Propan-2-ol
Name of manufacturer
INEOS Solvents Germany GmbH
Address of manufacturer
Römerstrasse 733, 47443 Moers Germany
Location of manufacturing sites
Römerstrasse 733, 47443 Moers Germany
Shamrockstraße 88, 44623 Herne Germany
2.   PRODUCT FAMILY COMPOSITION AND FORMULATION
2.1.    Qualitative and quantitative information on the composition of the family
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
Propan-2-ol
Active Substance
67-63-0
200-661-7
62,7
70,0
2.2.    Type(s) of formulation
Formulation(s)
Meta SPC 1: CL – Contact gel or Liquid
Meta SPC 3: CL – Contact gel or Liquid
Meta SPC 2: XX – Others: Ready-to-Use trigger spray
PART II
SECOND INFORMATION LEVEL – META SPC(S)
META SPC 1
1.   META SPC 1 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 1 identifier
Identifier
Meta SPC 1
1.2.    Suffix to the authorisation number
Number
1-1
1.3.    Product type(s)
Product type(s)
PT01 – Human hygiene (Disinfectants)
2.   META SPC 1 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
Propan-2-ol
Active Substance
67-63-0
200-661-7
62,7
70,0
2.2.    Type(s) of formulation of the meta SPC 1
Formulation(s)
Meta SPC 1: CL – Contact gel or Liquid
3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1
Hazard statements
Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements
If medical advice is needed, have product container or label at hand.
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
Keep container tightly closed.
Avoid breathing vapours.
Avoid breathing spray.
Use only outdoors or in a well-ventilated area.
Wear eye protection.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Call a POISON CENTER/doctor if you feel unwell.
If eye irritation persists:Get medical advice.
If eye irritation persists:Get medical attention.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of contents to in accordance with local regulations.
Dispose of container to in accordance with local regulations.
4.   AUTHORISED USE(S) OF THE META SPC 1
4.1.    Use description
Table 1
Use # 1 – Use 1 – Contact Gel or Liquid – Hygienic handrub – Professional user
Product type
PT01 – Human hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria (incl. Mycobacteria),
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Enveloped viruses
Common name: -
Development stage: -
Field(s) of use
Indoor
For professional use only. For use in private, public, healthcare and industrial areas and in areas for professional activities.
Application method(s)
Method: Direct application to both hands, rubbing
Detailed description:
-
Application rate(s) and frequency
Application Rate: 3 ml applied to one hand and complete surface of both hands are moistened and rubbed for 60 seconds per application.
Dilution (%): -
Number and timing of application:
Up to 25 disinfections per day, 5 day(s) per week
Category(ies) of users
Professional
Pack sizes and packaging material
—
Bottle HD-PE: 0,1L – 2,5L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP))
—
Can HD-PE: 5L – 60L; (Screw caps (PE/LDPE/HD-PE) or safety caps (HD-PE)
—
Drum HD-PE: 200L; (Plastic plug with venting system (HD-PE) or Plastic plug for tap (HD-PE) or plastic tap (HD-PE) or seal caps (HD-PE))
—
IBC container HD-PE: 1000L; (Screw caps (HD-PE)
4.1.1.    Use-specific instructions for use
See general directions for use.
4.1.2.    Use-specific risk mitigation measures
See general directions for use.
4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5.   GENERAL DIRECTIONS FOR USE  ( 1 ) OF THE META SPC 1
5.1.    Instructions for use
1)
For professional use only.
2)
Products must be shaken before use.
3)
Only apply on dry and visibly clean hands.
4)
For hand disinfection a ready-to-use gel or liquid (3 ml) is poured into the palms of one hand and the complete surface of both hands are moistened and rubbed for 60 seconds per application.
5.2.    Risk mitigation measures
1)
Avoid contact with eyes.
2)
Keep out of reach of children and pets.
3)
Use only in well-ventilated areas.
4)
For refilling a funnel must be applied.
5)
The following personal risk mitigation measure can be considered for refilling procedure unless it can be replaced by technical and/or organisational measures:
The use of eye protection during refilling of the product is recommended.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
1)
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
2)
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
5.4.    Instructions for safe disposal of the product and its packaging
1)
Product: Disposal together with normal waste is not allowed. Special disposal required according to local regulations.
2)
Do not let product enter drains.
3)
Contact waste disposal services.
4)
Contaminated packaging: Empty contaminated packaging thoroughly. They can be recycled after thorough and proper cleaning. Packaging that cannot be cleaned are to be disposed of in the same manner as the product.
5)
Do not burn, or use a cutting torch on, the empty drum. Risk of explosion.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
1)
Store in a well-ventilated place.
2)
Keep cool.
3)
Keep container tightly closed.
4)
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
5)
Shelf-life: 24 months
6.   OTHER INFORMATION
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m 3 for the professional user was agreed and used for the risk assessment of the product.
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Wofasept AHA
Market area: EU
Otovita® Professional Handgel
Market area: EU
Authorisation number
EU-0027707-0001 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
62,7
7.2.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Budenat® Protect Hand D807
Market area: EU
Authorisation number
EU-0027707-0002 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,0
7.3.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Handsteril OG
Market area: EU
Disinfection for Hands OG
Market area: EU
2-Propanol 70 %
Market area: EU
Isopropylalkohol Königseer Biozid
Market area: EU
Isogel Königseer Biozid Plus
Market area: EU
Isogel Königseer Biozid
Market area: EU
ISO 70
Market area: EU
Brensolv K68
Market area: EU
Isopropanol 70 Biocide
Market area: EU
Isopropanol 70
Market area: EU
Hand- und Oberflächendesinfektion
Market area: EU
Authorisation number
EU-0027707-0003 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
70,0
7.4.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Handsteril OG blau
Market area: EU
Authorisation number
EU-0027707-0004 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
65,0
7.5.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Easysept
Market area: EU
Authorisation number
EU-0027707-0005 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,0
7.6.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Witty-Lavalin D
Market area: EU
proCura Spray PUR
Market area: EU
Orlin Suprades HD
Market area: EU
Esept
Market area: EU
Bio Tec Des HD
Market area: EU
Authorisation number
EU-0027707-0006 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,1
7.7.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Curacid HD-sept
Market area: EU
Authorisation number
EU-0027707-0007 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
62,8
7.8.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Esept Gel
Market area: EU
Authorisation number
EU-0027707-0008 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,4
7.9.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Mano Germs
Market area: EU
Authorisation number
EU-0027707-0009 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,0
7.10.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Deogel Mani
Market area: EU
Deovet
Market area: EU
Deogel Hands
Market area: EU
Deomed
Market area: EU
Dermigel profumato
Market area: EU
Authorisation number
EU-0027707-0010 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
70,0
7.11.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Isogel
Market area: EU
Vetgel
Market area: EU
Icfgel
Market area: EU
Skingel
Market area: EU
Sanigel
Market area: EU
Dermigel
Market area: EU
Gel mimani
Market area: EU
Authorisation number
EU-0027707-0011 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
70,0
7.12.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Alcodet profumato
Market area: EU
Authorisation number
EU-0027707-0012 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
70,0
7.13.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Handsan
Market area: EU
Manisan
Market area: EU
Sanimed
Market area: EU
Authorisation number
EU-0027707-0013 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
70,0
7.14.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
ELIGEL
Market area: EU
Authorisation number
EU-0027707-0014 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
70,0
7.15.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
ELIGEL Perfum
Market area: EU
Authorisation number
EU-0027707-0015 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
70,0
7.16.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Desmila VSI
Market area: EU
mobilomed Skinsoft Expert
Market area: EU
SiMa CleanTecMano
Market area: EU
Funny Hygienikum
Market area: EU
Authorisation number
EU-0027707-0016 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
62,8
7.17.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Desmila VSI C
Market area: EU
Authorisation number
EU-0027707-0017 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,0
7.18.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Desmila LSI
Market area: EU
mobilomed Skinsoft Professional
Market area: EU
Authorisation number
EU-0027707-0018 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
64,7
7.19.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Desmila LSI C
Market area: EU
Authorisation number
EU-0027707-0019 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
64,7
7.20.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Desmila LSI pure
Market area: EU
Authorisation number
EU-0027707-0020 1-1
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
64,7
META SPC 2
1.   META SPC 2 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 2 identifier
Identifier
Meta SPC 2
1.2.    Suffix to the authorisation number
Number
1-2
1.3.    Product type(s)
Product type(s)
PT04 – Food and feed area (Disinfectants)
PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
2.   META SPC 2 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
Propan-2-ol
Active Substance
67-63-0
200-661-7
62,8
70,0
2.2.    Type(s) of formulation of the meta SPC 2
Formulation(s)
Meta SPC 2: XX – Others: Ready-to-Use trigger spray
3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
Hazard statements
Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements
If medical advice is needed, have product container or label at hand.
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
Keep container tightly closed.
Avoid breathing vapours.
Avoid breathing spray.
Use only outdoors or in a well-ventilated area.
Wear eye protection.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Call a POISON CENTER/doctor if you feel unwell.
If eye irritation persists:Get medical advice.
If eye irritation persists:Get medical attention.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of contents to in accordance with local regulations.
Dispose of container to in accordance with local regulations.
4.   AUTHORISED USE(S) OF THE META SPC 2
4.1.    Use description
Table 2
Use # 1 – Use 1 – Liquid Spray – Small surface disinfection – Professional user
Product type
PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant.
Target organism(s) (including development stage)
Scientific name: Bacteria (incl. Mycobacteria),
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of small non-porous surfaces, materials, equipment and furniture in private, public, healthcare, industrial areas and in areas for professional activities.
Application method(s)
Method: Spraying
Detailed description:
-
Application rate(s) and frequency
Application Rate: For surface disinfection a ready-to-use spray solution (20 ml/m 2 ) is applied on surfaces at room temperature.
Dilution (%): -
Number and timing of application:
Application according to requirements, one application per use, 4 times per day.
Small surface disinfection(other than healthcare):
Bactericidal and yeasticidal: contact time at least 1 min
In healthcare area:
Bactericidal and yeasticidal: contact time at least 5 min
Category(ies) of users
Professional
Pack sizes and packaging material
—
Bottle HD-PE: 0,1L – 2,5L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP))
—
Can HD-PE: 5L – 60L; (Screw caps (PE/LDPE/HD-PE) or safety caps (HD-PE)
—
Drum HD-PE: 200L; (Plastic plug with venting system (HD-PE) or Plastic plug for tap (HD-PE) or plastic tap (HD-PE) or seal caps (HD-PE))
—
IBC container HD-PE: 1000L; (Screw caps (HD-PE)
4.1.1.    Use-specific instructions for use
1)
Apply the ready-to-use product to the surface by spraying. Make sure to wet surfaces completely and wait for 1 minute (general surface disinfection) or 5 minutes (surfaces in healthcare area)
2)
For use at room temperature.
3)
Application according to requirements, one application per use, 4 times per day.
4.1.2.    Use-specific risk mitigation measures
The following personal risk mitigation measure can be considered for refilling procedure unless it can be replaced by technical and/or organisational measures:
The use of eye protection during refilling of the product is recommended.
4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
4.2.    Use description
Table 3
Use # 2 – Use 2 – Liquid Spray – Disinfection for small food contact surfaces – Professional user
Product type
PT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Field(s) of use
Indoor
Disinfection of small non-porous surfaces in food sector or food processing industries (including breweries, dairy industry and meat industry).
Application method(s)
Method: Spraying
Detailed description:
-
Application rate(s) and frequency
Application Rate: For surface disinfection a ready-to-use spray solution (20 ml/m 2 ) is applied on surfaces at room temperature.
Dilution (%): -
Number and timing of application:
Application according to requirements, one application per use, 4 times per day.
Small surface disinfection:
Bactericidal and yeasticidal: contact time at least 1 min
In Breweries/meat industry:
Bactericidal and yeasticidal: contact time at least 5 min
In dairy industry:
Bactericidal and yeasticidal: contact time at least 15 min
Category(ies) of users
Professional
Pack sizes and packaging material
—
Bottle HD-PE: 0,1L – 2,5L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP))
—
Can HD-PE: 5L – 60L; (Screw caps (PE/LDPE/HD-PE) or safety caps (HD-PE)
—
Drum HD-PE: 200L; (Plastic plug with venting system (HD-PE) or Plastic plug for tap (HD-PE) or plastic tap (HD-PE) or seal caps (HD-PE))
—
IBC container HD-PE: 1000L;(Screw caps (HD-PE)
4.2.1.    Use-specific instructions for use
1)
Apply the ready-to-use product to the surface by spraying. Make sure to wet surfaces completely and wait for at least 1 min (general surface disinfection), 5 min (surface disinfection in breweries or meat industry) or at least 15 min (surface disinfection in dairy industry).
2)
For use at room temperature.
3)
Application according to requirements, one application per use, 4 times per day.
4.2.2.    Use-specific risk mitigation measures
The following personal risk mitigation measure can be considered for disinfection of food processing machinery and refilling procedure unless it can be replaced by technical and/or organisational measures: The use of eye protection during handling of the product is recommended.
4.2.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.2.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.2.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5.   GENERAL DIRECTIONS FOR USE  ( 2 ) OF THE META SPC 2
5.1.    Instructions for use
1)
Products must be shaken before use.
2)
Do not apply more than 20 mL/m2.
3)
Used wipes must be disposed in a closed container.
5.2.    Risk mitigation measures
1)
Avoid contact with eyes.
2)
For refilling a funnel must be applied.
3)
The product must only be applied for disinfection of small surfaces.
4)
Keep out of reach of children and pets.
5)
Use only in well-ventilated areas.
6)
Keep children and pets away from rooms where disinfection is taking place.
7)
Provide adequate ventilation before children and pets enter treated rooms.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
1)
IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.
2)
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.
5.4.    Instructions for safe disposal of the product and its packaging
1)
Product: Disposal together with normal waste is not allowed. Special disposal required according to local regulations.
2)
Do not let product enter drains.
3)
Contact waste disposal services.
4)
Contaminated packaging: Empty contaminated packaging thoroughly. They can be recycled after thorough and proper cleaning. Packaging that cannot be cleaned are to be disposed of in the same manner as the product.
5)
Do not burn, or use a cutting torch on, the empty drum. Risk of explosion.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
1)
Store in a well-ventilated place.
2)
Keep cool.
3)
Keep container tightly closed.
4)
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
5)
Shelf-life: 24 months
6.   OTHER INFORMATION
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m 3 for the professional user was agreed and used for the risk assessment of the product.
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
proCura Spray PUR
Market area: EU
Witty-Express Ultra
Market area: EU
Witty-AQUA MEGA
Market area: EU
Anti-Germ DES ALC-IP
Market area: EU
BTS 6000
Market area: EU
Bio Tec Des AX
Market area: EU
Authorisation number
EU-0027707-0021 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,1
7.2.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Isopropanol 70 Biocide
Market area: EU
Isopropanol 70
Market area: EU
Isopropylalkohol Königseer Biozid
Market area: EU
Isogel Königseer Biozid Plus
Market area: EU
Gold
Market area: EU
Füllersteril PPP
Market area: EU
Isopropylalkohol 70 % Gew.
Market area: EU
Fast Germs
Market area: EU
BACTINYL IPA 70 %
Market area: EU
SAFE CLEANER SR
Market area: EU
Isopropylalkohol Königseer Flächen Biozid
Market area: EU
Isonet
Market area: EU
Isonet AL
Market area: EU
Sanificante Alcolico
Market area: EU
Isogerm
Market area: EU
Isogerm AL
Market area: EU
Isonet PU
Market area: EU
Alidet
Market area: EU
Sanocasa
Market area: EU
Frigosano
Market area: EU
Hygien Food
Market area: EU
Medicalsan
Market area: EU
Alcohol Sanitized
Market area: EU
Alkosan
Market area: EU
Biofarm
Market area: EU
Allkill
Market area: EU
DETERQUAT PRO SR
Market area: EU
Galtec Isoprop Bactericide
Market area: EU
Amphisol 70
Market area: EU
AISW 100
Market area: EU
Steril Spray PPP
Market area: EU
Hand- und Oberflächendesinfektion
Market area: EU
Authorisation number
EU-0027707-0022 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
70,0
7.3.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Budenat® Rapid Effect D 446
Market area: EU
IPA 300
Market area: EU
Easydes IPA
Market area: EU
Sonet
Market area: EU
Sonet Forte
Market area: EU
Isosan Forte
Market area: EU
Germisan
Market area: EU
Sanivet
Market area: EU
Alidet Forte
Market area: EU
Germodet
Market area: EU
Isoclean
Market area: EU
Alcohol Sanitized Strong
Market area: EU
Alkosan Strong
Market area: EU
Isonet Strong
Market area: EU
Desmila HSI
Market area: EU
Vetasept pur
Market area: EU
Authorisation number
EU-0027707-0023 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,0
7.4.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Isopropanol/Wasser 65/35 %
Market area: EU
Authorisation number
EU-0027707-0024 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
65,0
7.5.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Curacid Food Rapid
Market area: EU
Dr Desi Küchendesinfektion
Market area: EU
Authorisation number
EU-0027707-0025 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
62,8
7.6.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Deogerm
Market area: EU
Deosan
Market area: EU
Medicaldeo
Market area: EU
Deonet
Market area: EU
Deofloor
Market area: EU
Sanocasa Profumato
Market area: EU
Authorisation number
EU-0027707-0026 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,0
7.7.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Desmila HSI C
Market area: EU
Vetasept Lemon
Market area: EU
Authorisation number
EU-0027707-0027 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,0
7.8.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Desmila HSI D
Market area: EU
Vetasept Fresh
Market area: EU
Authorisation number
EU-0027707-0028 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,0
7.9.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Desmila HSI P
Market area: EU
Vetasept Pfirsich
Market area: EU
Authorisation number
EU-0027707-0029 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,0
7.10.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Desmila AFI
Market area: EU
Hygienic I
Market area: EU
Authorisation number
EU-0027707-0030 1-2
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
64,7
META SPC 3
1.   META SPC 3 ADMINISTRATIVE INFORMATION
1.1.    Meta SPC 3 identifier
Identifier
Meta SPC 3
1.2.    Suffix to the authorisation number
Number
1-3
1.3.    Product type(s)
Product type(s)
PT01 – Human hygiene (Disinfectants)
2.   META SPC 3 COMPOSITION
2.1.    Qualitative and quantitative information on the composition of the meta SPC 3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Min
Max
Propan-2-ol
Active Substance
67-63-0
200-661-7
62,7
70,0
2.2.    Type(s) of formulation of the meta SPC 3
Formulation(s)
Meta SPC 3: CL – Contact gel or Liquid
3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
Hazard statements
Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.
Precautionary statements
If medical advice is needed, have product container or label at hand.
Keep out of reach of children.
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
Keep container tightly closed.
Avoid breathing vapours.
Avoid breathing spray.
Use only outdoors or in a well-ventilated area.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Call a POISON CENTER/doctor if you feel unwell.
If eye irritation persists:Get medical advice.
If eye irritation persists:Get medical attention.
Store in a well-ventilated place.Keep cool.
Store locked up.
Dispose of contents to in accordance with local regulations.
Dispose of container to in accordance with local regulations.
4.   AUTHORISED USE(S) OF THE META SPC 3
4.1.    Use description
Table 4
Use # 1 – Use 1 – Contact Gel or Liquid – Hygienic handrub – Non-professional user
Product type
PT01 – Human hygiene (Disinfectants)
Where relevant, an exact description of the authorised use
Not relevant
Target organism(s) (including development stage)
Scientific name: Bacteria (incl. Mycobacteria),
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Enveloped viruses
Common name: -
Development stage: -
Field(s) of use
Indoor
For use in private and public areas.
Application method(s)
Method: Direct application to both hands, rubbing
Detailed description:
-
Application rate(s) and frequency
Application Rate: 3 ml applied to one hand and complete surface of both hands are moistened and rubbed for 60 seconds per application.
Dilution (%): -
Number and timing of application:
Up to 5 disinfections per day, 5 day(s) per week
Category(ies) of users
General public (non-professional)
Pack sizes and packaging material
Bottle HD-PE: 0,1L – 1,0L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP))
4.1.1.    Use-specific instructions for use
See general directions for use.
4.1.2.    Use-specific risk mitigation measures
See general directions for use.
4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
See general directions for use.
4.1.4.    Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
See general directions for use.
5.   GENERAL DIRECTIONS FOR USE  ( 3 ) OF THE META SPC 3
5.1.    Instructions for use
1)
Comply with the instructions for use.
2)
Products must be shaken before use.
3)
Only apply on dry and visibly clean hands.
4)
For hand disinfection a ready-to-use gel or liquid (3 ml) is poured into the palms of one hand and the complete surface of both hands are moistened and rubbed for 60 seconds per application.
5)
The authorisation holder has to specify the typical application rate in a simple, easily understandable form on the label:
—
Trigger spray: Apply 3 or 4 spray strokes (depending on the trigger spray cap)
—
Pump spray: Apply 3 pump strokes
—
Bottle: Visual observation
5.2.    Risk mitigation measures
1)
Avoid contact with eyes.
2)
Use by children only under supervision of an adult.
3)
Use only in well-ventilated areas.
5.3.    Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
1)
If medical advice is needed, have product container or label at hand.
2)
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing for five minutes.
3)
Call a POISON CENTER or doctor if you feel unwell.
4)
If eye irritation persists: Get medical advice/attention.
5)
IF INHALED OR SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor.
5.4.    Instructions for safe disposal of the product and its packaging
1)
Product: Disposal together with normal waste is not allowed. Special disposal required according to local regulations.
2)
Do not let product enter drains.
3)
Contact waste disposal services.
4)
Contaminated packaging: Empty contaminated packaging thoroughly. They can be recycled after thorough and proper cleaning. Packaging that cannot be cleaned are to be disposed of in the same manner as the product.
5)
Do not burn, or use a cutting torch on, the empty drum. Risk of explosion.
5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage
1)
Store in a well-ventilated place.
2)
Keep cool.
3)
Keep container tightly closed.
4)
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
5)
Keep out of reach of children and pets.
6)
Shelf-life: 24 months
6.   OTHER INFORMATION
-
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
7.1.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Frend Hand Sanitiser Gel
Market area: EU
Authorisation number
EU-0027707-0031 1-3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
65,3
7.2.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Biogat H-Des
Market area: EU
Authorisation number
EU-0027707-0032 1-3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
70,0
7.3.    Trade name(s), authorisation number and specific composition of each individual product
Trade name(s)
Neo-Amisept
Market area: EU
Authorisation number
EU-0027707-0033 1-3
Common name
IUPAC name
Function
CAS number
EC number
Content (%)
Propan-2-ol
Active Substance
67-63-0
200-661-7
63,0
( 1 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.
( 2 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.
( 3 )   Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.
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)

Schedules & Appendices

Cite this act
