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)
Date: 2022-11-11
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, biocide, chemical product, decontamination, food safety, market approval, pharmaceutical product








L_2022297EN.01000101.xml










17.11.2022   


EN


Official Journal of the European Union


L 297/1








            COMMISSION IMPLEMENTING REGULATION (EU) 2022/2252
of 11 November 2022
         
granting a Union authorisation for the biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’
         
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

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


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

Whereas:







(1)


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












(2)


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












(3)


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












(4)


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












(5)


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












(6)


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












(7)


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












(8)


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





HAS ADOPTED THIS REGULATION:



Article 1
A Union authorisation with authorisation number EU-0027707-0000 is granted to Brenntag GmbH for the making available on the market and use of the biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union Authorisation is valid from 7 December 2022 to 30 November 2032.


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




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 11 November 2022.


For the Commission


The President

Ursula VON DER LEYEN
            





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

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




ANNEX

Summary of product characteristics for a biocidal product family

Brenntag GmbH Propan-2-ol Product Family
Product type 1 – Human hygiene (Disinfectants)
Product type 4 – Food and feed area (Disinfectants)
Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
Authorisation number: EU-0027707-0000
R4BP asset number: EU-0027707-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION
1.1.   Family name







Name


Brenntag GmbH Propan-2-ol Product Family




1.2.   Product type(s)







Product type(s)


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




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


Brenntag GmbH




Address


Messeallee 11, 45131 Essen Germany




Authorisation number


EU-0027707-0000





R4BP asset number



EU-0027707-0000




Date of the authorisation


7 December 2022




Expiry date of the authorisation


30 November 2032




1.4.   Manufacturer(s) of the biocidal products







Name of manufacturer


Kesla Pharma Wolfen GmbH




Address of manufacturer


Kesla-Str. 1, 06803 Bitterfeld Germany




Location of manufacturing sites


Kesla-Str. 1, 06803 Bitterfeld Germany













Name of manufacturer


Dreve GmbH




Address of manufacturer


Max-Planck-Str. 31, 59423 Unna Germany




Location of manufacturing sites


Kesla Pharma Wolfen GmbH, Kesla-Str. 1, 06803 Bitterfeld Germany













Name of manufacturer


Buzil-Werk Wagner GmbH & Co. KG




Address of manufacturer


Fraunhoferstr. 17, 87700 Memmingen Germany




Location of manufacturing sites


Fraunhoferstr. 17, 87700 Memmingen Germany













Name of manufacturer


Wigol W. Stache GmbH




Address of manufacturer


Textorstr. 2, 67547 Worms Germany




Location of manufacturing sites


Textorstr. 2, 67547 Worms Germany













Name of manufacturer


KiiltoClean Oy




Address of manufacturer


Tengströminkatu 6, FI-20630 Turku Finland




Location of manufacturing sites


PL 157, FI-20101 Turku Finland













Name of manufacturer


Witty GmbH und Co. KG




Address of manufacturer


Herrenrothstr. 12, 86424 Dinkelscherben Germany




Location of manufacturing sites


Herrenrothstr. 12, 86424 Dinkelscherben Germany













Name of manufacturer


Carl Roth GmbH und Co. KG




Address of manufacturer


An der Mole 5, 76189 Karlsruhe Germany




Location of manufacturing sites


An der Mole 5, 76189 Karlsruhe Germany













Name of manufacturer


Pro-cura Hy-med GmbH




Address of manufacturer


Stresemannstrasse 364, 22761 Hamburg Germany




Location of manufacturing sites


A.F.P., Otto-Brenner-Str. 16, 21337 Lüneburg Germany













Name of manufacturer


Pico-medical GmbH




Address of manufacturer


Fangdieckstr. 24, 22547 Hamburg Germany




Location of manufacturing sites


A.F.P., Otto-Brenner-Str. 16, 21337 Lüneburg Germany













Name of manufacturer


Anti-Germ International GmbH




Address of manufacturer


Oberbrühlstr. 16, 87700 Memmingen Germany




Location of manufacturing sites


Oberbrühlstr. 16, 87700 Memmingen Germany













Name of manufacturer


LCI FLOWEY




Address of manufacturer


2 ZAC Klengbusbierg, 7795 Bissen Luxembourg




Location of manufacturing sites


2 ZAC Klengbusbierg, 7795 Bissen Luxembourg













Name of manufacturer


Hofmann & Sommer GmbH und Co. KG




Address of manufacturer


Lindenstr.11, 07426 Königsee-Rottenbach Germany




Location of manufacturing sites


Lindenstr.11, 07426 Königsee-Rottenbach Germany













Name of manufacturer


Girelli Alcool srl




Address of manufacturer


Via Thomas Edison 5, 20080 Zibido San Giacomo (MI) Italy




Location of manufacturing sites


Via Thomas Edison 5, 20080 Zibido San Giacomo (MI) Italy













Name of manufacturer


Brenntag S.p.A.




Address of manufacturer


Via Cusago 150/4, 20158 Milano (MI) Italy




Location of manufacturing sites


Via Cusago 150/4, 20158 Milano (MI) Italy













Name of manufacturer


I.C.F. Srl




Address of manufacturer


Via G.B. Benzoni 50, 26020 Palazzo Pignano (CR) Italy




Location of manufacturing sites


Via G.B. Benzoni 50, 26020 Palazzo Pignano (CR) Italy













Name of manufacturer


Brenntag SA




Address of manufacturer


90 Avenue du Progrès, 69 680 Chassieu France




Location of manufacturing sites


90 Avenue du Progrès, 69 680 Chassieu France













Name of manufacturer


Brenntag GmbH




Address of manufacturer


Stinnes-Platz 1, 45472 Muelheim a.d. Ruhr Germany




Location of manufacturing sites


Stinnes-Platz 1, 45472 Muelheim a.d. Ruhr Germany













Name of manufacturer


BCD Chemie GmbH




Address of manufacturer


Schellerdamm 16, 21079 Hamburg Germany




Location of manufacturing sites


Schellerdamm 16, 21079 Hamburg Germany













Name of manufacturer


HYDRACHIM




Address of manufacturer


Z.A. ROUTE DE ST POIX, 35370 LE PERTRE France




Location of manufacturing sites


Z.A. du piquet, 35370 Etrelles France













Name of manufacturer


Langguth Chemie GmbH




Address of manufacturer


Wandalenstrasse 6, 86343 Königsbrunn Germany




Location of manufacturing sites


Wandalenstrasse 6, 86343 Königsbrunn Germany













Name of manufacturer


Burgess Galvin & Co




Address of manufacturer


Jamestown Road, 11 Finglas, Dublin Ireland




Location of manufacturing sites


Jamestown Road, 11 Finglas, Dublin Ireland













Name of manufacturer


Tristel




Address of manufacturer


Lynx Business Park, Fordham Road, CB8 7NY Snailwell, Cambridge United Kingdom




Location of manufacturing sites


Lynx Business Park, Fordham Road, CB8 7NY Snailwell, Cambridge United Kingdom













Name of manufacturer


Brenntag Schweizerhall




Address of manufacturer


Elsässerstrasse 231, 4056 Basel Switzerland




Location of manufacturing sites


Elsässerstrasse 231, 4056 Basel Switzerland













Name of manufacturer


ORAPI




Address of manufacturer


5 Allee des Cerdes, Pi de la Plaine de L’ain, 01150 Saint Vulbas France




Location of manufacturing sites


5 Allee des Cerdes, Pi de la Plaine de L’ain, 01150 Saint Vulbas France













Name of manufacturer


Copak S.A.




Address of manufacturer


Z.I. du Madrillet, rue de la Chênaie, 76800 Saint-Etienne-du-Rouvray France




Location of manufacturing sites


Z.I. du Madrillet, rue de la Chênaie, 76800 Saint-Etienne-du-Rouvray France













Name of manufacturer


Water Technology Limited




Address of manufacturer


TOGHER INDUSTRIAL EST, T12KPF2 CORK, DUBLIN Ireland




Location of manufacturing sites


TOGHER INDUSTRIAL EST, T12KPF2 CORK, DUBLIN Ireland













Name of manufacturer


AF International, Electrolube: Divisions of H K Wentworth Ltd




Address of manufacturer


AASHBY PARK, COALFIELD WAY, ASHBY DE LA ZOUCH, LE65 1JF LEICESTERSHIRE United Kingdom




Location of manufacturing sites


AASHBY PARK, COALFIELD WAY, ASHBY DE LA ZOUCH, LE65 1JF LEICESTERSHIRE United Kingdom













Name of manufacturer


Bello Mondo bvba




Address of manufacturer


Helststraat 150-159, 2630 Aartselaar Belgium




Location of manufacturing sites


Laboratoria Smeets N.V., Fotografielaan 42, B-2610 Antwerpen-Wilrijk Belgium













Name of manufacturer


CERICHEM BIOPHARM SRL




Address of manufacturer


Viale Einaudi snc (z.i.), 71042 Cerignola (FG) Italy




Location of manufacturing sites


Viale Einaudi snc (z.i.), 71042 Cerignola (FG) Italy













Name of manufacturer


Otto Fischar GmbH & Co. KG




Address of manufacturer


Kaiserstr. 221, 66133 Saarbruecken Germany




Location of manufacturing sites


Kaiserstr. 221, 66133 Saarbruecken Germany













Name of manufacturer


Caesar & Loretz GmbH




Address of manufacturer


Herderstr. 31, 40721 Hilden Germany




Location of manufacturing sites


Herderstr. 31, 40721 Hilden Germany













Name of manufacturer


Karl-Josef Kost Alkohole & Produkte aus Alkohol KG




Address of manufacturer


Rauentalshöhe 4, 56073 Koblenz Germany




Location of manufacturing sites


Rauentalshöhe 4, 56073 Koblenz Germany




1.5.   Manufacturer(s) of the active substance(s)







Active substance


Propan-2-ol




Name of manufacturer


ExxonMobil




Address of manufacturer


4999 Scenic Highway, LA 70897 Baton Rouge, Louisiana United States




Location of manufacturing sites


4999 Scenic Highway, LA 70897 Baton Rouge, Louisiana United States













Active substance


Propan-2-ol




Name of manufacturer


Shell Nederland Raffinaderij B.V.




Address of manufacturer


Vondelingenweg 601, Vodelingenenplaat, 3196 KK Rotterdam Netherlands




Location of manufacturing sites


Vondelingenweg 601, Vodelingenenplaat, 3196 KK Rotterdam Netherlands













Active substance


Propan-2-ol




Name of manufacturer


INEOS Solvents Germany GmbH




Address of manufacturer


Römerstrasse 733, 47443 Moers Germany




Location of manufacturing sites


Römerstrasse 733, 47443 Moers Germany
Shamrockstraße 88, 44623 Herne Germany




2.   PRODUCT FAMILY COMPOSITION AND FORMULATION
2.1.   Qualitative and quantitative information on the composition of the family












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


62,7 


70,0 




2.2.   Type(s) of formulation







Formulation(s)


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




PART II

SECOND INFORMATION LEVEL – META SPC(S)


META SPC 1

1.   META SPC 1 ADMINISTRATIVE INFORMATION
1.1.   Meta SPC 1 identifier







Identifier


Meta SPC 1




1.2.   Suffix to the authorisation number







Number


1-1




1.3.   Product type(s)







Product type(s)


PT01 – Human hygiene (Disinfectants)




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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


62,7 


70,0 




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







Formulation(s)


Meta SPC 1: CL – Contact gel or Liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1






Hazard statements


Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.




Precautionary statements


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




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


Table 1


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







Product type


PT01 – Human hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: Bacteria (incl. Mycobacteria),
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Enveloped viruses
Common name: -
Development stage: -




Field(s) of use


Indoor
For professional use only. For use in private, public, healthcare and industrial areas and in areas for professional activities.




Application method(s)


Method: Direct application to both hands, rubbing
Detailed description:
-




Application rate(s) and frequency


Application Rate: 3 ml applied to one hand and complete surface of both hands are moistened and rubbed for 60 seconds per application.
Dilution (%): -
Number and timing of application:
Up to 25 disinfections per day, 5 day(s) per week




Category(ies) of users


Professional




Pack sizes and packaging material








—


Bottle HD-PE: 0,1L – 2,5L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP))










—


Can HD-PE: 5L – 60L; (Screw caps (PE/LDPE/HD-PE) or safety caps (HD-PE)










—


Drum HD-PE: 200L; (Plastic plug with venting system (HD-PE) or Plastic plug for tap (HD-PE) or plastic tap (HD-PE) or seal caps (HD-PE))










—


IBC container HD-PE: 1000L; (Screw caps (HD-PE)








4.1.1.   Use-specific instructions for use

See general directions for use.
4.1.2.   Use-specific risk mitigation measures

See general directions for use.
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.
5.   GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1
5.1.   Instructions for use







1)


For professional use only.










2)


Products must be shaken before use.










3)


Only apply on dry and visibly clean hands.










4)


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




5.2.   Risk mitigation measures







1)


Avoid contact with eyes.










2)


Keep out of reach of children and pets.










3)


Use only in well-ventilated areas.










4)


For refilling a funnel must be applied.










5)


The following personal risk mitigation measure can be considered for refilling procedure unless it can be replaced by technical and/or organisational measures:




The use of eye protection during refilling of the product is recommended.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment







1)


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










2)


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




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







1)


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










2)


Do not let product enter drains.










3)


Contact waste disposal services.










4)


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










5)


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




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







1)


Store in a well-ventilated place.










2)


Keep cool.










3)


Keep container tightly closed.










4)


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










5)


Shelf-life: 24 months




6.   OTHER INFORMATION
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
7.1.   Trade name(s), authorisation number and specific composition of each individual product












Trade name(s)


Wofasept AHA


Market area: EU




 


Otovita® Professional Handgel


Market area: EU




Authorisation number


EU-0027707-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


62,7 




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












Trade name(s)


Budenat® Protect Hand D807


Market area: EU




Authorisation number


EU-0027707-0002 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,0 




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












Trade name(s)


Handsteril OG


Market area: EU




Disinfection for Hands OG


Market area: EU




2-Propanol 70 %


Market area: EU




Isopropylalkohol Königseer Biozid


Market area: EU




Isogel Königseer Biozid Plus


Market area: EU




Isogel Königseer Biozid


Market area: EU




ISO 70


Market area: EU




Brensolv K68


Market area: EU




Isopropanol 70 Biocide


Market area: EU




Isopropanol 70


Market area: EU




Hand- und Oberflächendesinfektion


Market area: EU




Authorisation number


EU-0027707-0003 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


70,0 




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












Trade name(s)


Handsteril OG blau


Market area: EU




Authorisation number


EU-0027707-0004 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


65,0 




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












Trade name(s)


Easysept


Market area: EU




Authorisation number


EU-0027707-0005 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,0 




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












Trade name(s)


Witty-Lavalin D


Market area: EU




proCura Spray PUR


Market area: EU




Orlin Suprades HD


Market area: EU




Esept


Market area: EU




Bio Tec Des HD


Market area: EU




Authorisation number


EU-0027707-0006 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,1 




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












Trade name(s)


Curacid HD-sept


Market area: EU




Authorisation number


EU-0027707-0007 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


62,8 




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












Trade name(s)


Esept Gel


Market area: EU




Authorisation number


EU-0027707-0008 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,4 




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












Trade name(s)


Mano Germs


Market area: EU




Authorisation number


EU-0027707-0009 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,0 




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












Trade name(s)


Deogel Mani


Market area: EU




Deovet


Market area: EU




Deogel Hands


Market area: EU




Deomed


Market area: EU




Dermigel profumato


Market area: EU




Authorisation number


EU-0027707-0010 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


70,0 




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












Trade name(s)


Isogel


Market area: EU




Vetgel


Market area: EU




Icfgel


Market area: EU




Skingel


Market area: EU




Sanigel


Market area: EU




Dermigel


Market area: EU




Gel mimani


Market area: EU




Authorisation number


EU-0027707-0011 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


70,0 




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












Trade name(s)


Alcodet profumato


Market area: EU




Authorisation number


EU-0027707-0012 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


70,0 




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












Trade name(s)


Handsan


Market area: EU




Manisan


Market area: EU




Sanimed


Market area: EU




Authorisation number


EU-0027707-0013 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


70,0 




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












Trade name(s)


ELIGEL


Market area: EU




Authorisation number


EU-0027707-0014 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


70,0 




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












Trade name(s)


ELIGEL Perfum


Market area: EU




Authorisation number


EU-0027707-0015 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


70,0 




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












Trade name(s)


Desmila VSI


Market area: EU




mobilomed Skinsoft Expert


Market area: EU




SiMa CleanTecMano


Market area: EU




Funny Hygienikum


Market area: EU




Authorisation number


EU-0027707-0016 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


62,8 




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












Trade name(s)


Desmila VSI C


Market area: EU




Authorisation number


EU-0027707-0017 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,0 




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












Trade name(s)


Desmila LSI


Market area: EU




mobilomed Skinsoft Professional


Market area: EU




Authorisation number


EU-0027707-0018 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


64,7 




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












Trade name(s)


Desmila LSI C


Market area: EU




Authorisation number


EU-0027707-0019 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


64,7 




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












Trade name(s)


Desmila LSI pure


Market area: EU




Authorisation number


EU-0027707-0020 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


64,7 





META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION
1.1.   Meta SPC 2 identifier







Identifier


Meta SPC 2




1.2.   Suffix to the authorisation number







Number


1-2




1.3.   Product type(s)







Product type(s)


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




2.   META SPC 2 COMPOSITION
2.1.   Qualitative and quantitative information on the composition of the meta SPC 2












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


62,8 


70,0 




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







Formulation(s)


Meta SPC 2: XX – Others: Ready-to-Use trigger spray




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2






Hazard statements


Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.




Precautionary statements


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




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


Table 2


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







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant.




Target organism(s) (including development stage)


Scientific name: Bacteria (incl. Mycobacteria),
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of small non-porous surfaces, materials, equipment and furniture in private, public, healthcare, industrial areas and in areas for professional activities.




Application method(s)


Method: Spraying
Detailed description:
-




Application rate(s) and frequency


Application Rate: For surface disinfection a ready-to-use spray solution (20 ml/m2) is applied on surfaces at room temperature.
Dilution (%): -
Number and timing of application:






 


Application according to requirements, one application per use, 4 times per day.




Small surface disinfection(other than healthcare):






 


Bactericidal and yeasticidal: contact time at least 1 min




In healthcare area:






 


Bactericidal and yeasticidal: contact time at least 5 min








Category(ies) of users


Professional




Pack sizes and packaging material








—


Bottle HD-PE: 0,1L – 2,5L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP))










—


Can HD-PE: 5L – 60L; (Screw caps (PE/LDPE/HD-PE) or safety caps (HD-PE)










—


Drum HD-PE: 200L; (Plastic plug with venting system (HD-PE) or Plastic plug for tap (HD-PE) or plastic tap (HD-PE) or seal caps (HD-PE))










—


IBC container HD-PE: 1000L; (Screw caps (HD-PE)








4.1.1.   Use-specific instructions for use







1)


Apply the ready-to-use product to the surface by spraying. Make sure to wet surfaces completely and wait for 1 minute (general surface disinfection) or 5 minutes (surfaces in healthcare area)










2)


For use at room temperature.










3)


Application according to requirements, one application per use, 4 times per day.




4.1.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be considered for refilling procedure unless it can be replaced by technical and/or organisational measures:
The use of eye protection during refilling of the product is recommended.
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.
4.2.   Use description


Table 3


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







Product type


PT04 – Food and feed area (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: Bacteria
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -




Field(s) of use


Indoor
Disinfection of small non-porous surfaces in food sector or food processing industries (including breweries, dairy industry and meat industry).




Application method(s)


Method: Spraying
Detailed description:
-




Application rate(s) and frequency


Application Rate: For surface disinfection a ready-to-use spray solution (20 ml/m2) is applied on surfaces at room temperature.
Dilution (%): -
Number and timing of application:






 


Application according to requirements, one application per use, 4 times per day.




Small surface disinfection:






 


Bactericidal and yeasticidal: contact time at least 1 min




In Breweries/meat industry:






 


Bactericidal and yeasticidal: contact time at least 5 min




In dairy industry:






 


Bactericidal and yeasticidal: contact time at least 15 min








Category(ies) of users


Professional




Pack sizes and packaging material








—


Bottle HD-PE: 0,1L – 2,5L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP))










—


Can HD-PE: 5L – 60L; (Screw caps (PE/LDPE/HD-PE) or safety caps (HD-PE)










—


Drum HD-PE: 200L; (Plastic plug with venting system (HD-PE) or Plastic plug for tap (HD-PE) or plastic tap (HD-PE) or seal caps (HD-PE))










—


IBC container HD-PE: 1000L;(Screw caps (HD-PE)








4.2.1.   Use-specific instructions for use







1)


Apply the ready-to-use product to the surface by spraying. Make sure to wet surfaces completely and wait for at least 1 min (general surface disinfection), 5 min (surface disinfection in breweries or meat industry) or at least 15 min (surface disinfection in dairy industry).










2)


For use at room temperature.










3)


Application according to requirements, one application per use, 4 times per day.




4.2.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be considered for disinfection of food processing machinery and refilling procedure unless it can be replaced by technical and/or organisational measures: The use of eye protection during handling of the product is recommended.
4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.
5.   GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2
5.1.   Instructions for use







1)


Products must be shaken before use.










2)


Do not apply more than 20 mL/m2.










3)


Used wipes must be disposed in a closed container.




5.2.   Risk mitigation measures







1)


Avoid contact with eyes.










2)


For refilling a funnel must be applied.










3)


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










4)


Keep out of reach of children and pets.










5)


Use only in well-ventilated areas.










6)


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










7)


Provide adequate ventilation before children and pets enter treated rooms.




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







1)


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










2)


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




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







1)


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










2)


Do not let product enter drains.










3)


Contact waste disposal services.










4)


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










5)


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




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







1)


Store in a well-ventilated place.










2)


Keep cool.










3)


Keep container tightly closed.










4)


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










5)


Shelf-life: 24 months




6.   OTHER INFORMATION
The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
7.1.   Trade name(s), authorisation number and specific composition of each individual product












Trade name(s)


proCura Spray PUR


Market area: EU




Witty-Express Ultra


Market area: EU




Witty-AQUA MEGA


Market area: EU




Anti-Germ DES ALC-IP


Market area: EU




BTS 6000


Market area: EU




Bio Tec Des AX


Market area: EU




Authorisation number


EU-0027707-0021 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,1 




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












Trade name(s)


Isopropanol 70 Biocide


Market area: EU




Isopropanol 70


Market area: EU




Isopropylalkohol Königseer Biozid


Market area: EU




Isogel Königseer Biozid Plus


Market area: EU




Gold


Market area: EU




Füllersteril PPP


Market area: EU




Isopropylalkohol 70 % Gew.


Market area: EU




Fast Germs


Market area: EU




BACTINYL IPA 70 %


Market area: EU




SAFE CLEANER SR


Market area: EU




Isopropylalkohol Königseer Flächen Biozid


Market area: EU




Isonet


Market area: EU




Isonet AL


Market area: EU




Sanificante Alcolico


Market area: EU




Isogerm


Market area: EU




Isogerm AL


Market area: EU




Isonet PU


Market area: EU




Alidet


Market area: EU




Sanocasa


Market area: EU




Frigosano


Market area: EU




Hygien Food


Market area: EU




Medicalsan


Market area: EU




Alcohol Sanitized


Market area: EU




Alkosan


Market area: EU




Biofarm


Market area: EU




Allkill


Market area: EU




DETERQUAT PRO SR


Market area: EU




Galtec Isoprop Bactericide


Market area: EU




Amphisol 70


Market area: EU




AISW 100


Market area: EU




Steril Spray PPP


Market area: EU




Hand- und Oberflächendesinfektion


Market area: EU




Authorisation number


EU-0027707-0022 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


70,0 




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












Trade name(s)


Budenat® Rapid Effect D 446


Market area: EU




IPA 300


Market area: EU




Easydes IPA


Market area: EU




Sonet


Market area: EU




Sonet Forte


Market area: EU




Isosan Forte


Market area: EU




Germisan


Market area: EU




Sanivet


Market area: EU




Alidet Forte


Market area: EU




Germodet


Market area: EU




Isoclean


Market area: EU




Alcohol Sanitized Strong


Market area: EU




Alkosan Strong


Market area: EU




Isonet Strong


Market area: EU




Desmila HSI


Market area: EU




Vetasept pur


Market area: EU




Authorisation number


EU-0027707-0023 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,0 




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












Trade name(s)


Isopropanol/Wasser 65/35 %


Market area: EU




Authorisation number


EU-0027707-0024 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


65,0 




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












Trade name(s)


Curacid Food Rapid


Market area: EU




Dr Desi Küchendesinfektion


Market area: EU




Authorisation number


EU-0027707-0025 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


62,8 




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












Trade name(s)


Deogerm


Market area: EU




Deosan


Market area: EU




Medicaldeo


Market area: EU




Deonet


Market area: EU




Deofloor


Market area: EU




Sanocasa Profumato


Market area: EU




Authorisation number


EU-0027707-0026 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,0 




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












Trade name(s)


Desmila HSI C


Market area: EU




Vetasept Lemon


Market area: EU




Authorisation number


EU-0027707-0027 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,0 




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












Trade name(s)


Desmila HSI D


Market area: EU




Vetasept Fresh


Market area: EU




Authorisation number


EU-0027707-0028 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,0 




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












Trade name(s)


Desmila HSI P


Market area: EU




Vetasept Pfirsich


Market area: EU




Authorisation number


EU-0027707-0029 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,0 




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












Trade name(s)


Desmila AFI


Market area: EU




Hygienic I


Market area: EU




Authorisation number


EU-0027707-0030 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


64,7 





META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION
1.1.   Meta SPC 3 identifier







Identifier


Meta SPC 3




1.2.   Suffix to the authorisation number







Number


1-3




1.3.   Product type(s)







Product type(s)


PT01 – Human hygiene (Disinfectants)




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












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


62,7 


70,0 




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







Formulation(s)


Meta SPC 3: CL – Contact gel or Liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3






Hazard statements


Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause drowsiness or dizziness.
Repeated exposure may cause skin dryness or cracking.




Precautionary statements


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




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


Table 4


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







Product type


PT01 – Human hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


Not relevant




Target organism(s) (including development stage)


Scientific name: Bacteria (incl. Mycobacteria),
Common name: -
Development stage: -
Scientific name: Yeast
Common name: -
Development stage: -
Scientific name: Enveloped viruses
Common name: -
Development stage: -




Field(s) of use


Indoor
For use in private and public areas.




Application method(s)


Method: Direct application to both hands, rubbing
Detailed description:
-




Application rate(s) and frequency


Application Rate: 3 ml applied to one hand and complete surface of both hands are moistened and rubbed for 60 seconds per application.
Dilution (%): -
Number and timing of application:
Up to 5 disinfections per day, 5 day(s) per week




Category(ies) of users


General public (non-professional)




Pack sizes and packaging material


Bottle HD-PE: 0,1L – 1,0L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP))




4.1.1.   Use-specific instructions for use

See general directions for use.
4.1.2.   Use-specific risk mitigation measures

See general directions for use.
4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.
5.   GENERAL DIRECTIONS FOR USE (3) OF THE META SPC 3
5.1.   Instructions for use







1)


Comply with the instructions for use.










2)


Products must be shaken before use.










3)


Only apply on dry and visibly clean hands.










4)


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










5)


The authorisation holder has to specify the typical application rate in a simple, easily understandable form on the label:






—


Trigger spray: Apply 3 or 4 spray strokes (depending on the trigger spray cap)










—


Pump spray: Apply 3 pump strokes










—


Bottle: Visual observation








5.2.   Risk mitigation measures







1)


Avoid contact with eyes.










2)


Use by children only under supervision of an adult.










3)


Use only in well-ventilated areas.




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







1)


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










2)


IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing for five minutes.










3)


Call a POISON CENTER or doctor if you feel unwell.










4)


If eye irritation persists: Get medical advice/attention.










5)


IF INHALED OR SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor.




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







1)


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










2)


Do not let product enter drains.










3)


Contact waste disposal services.










4)


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










5)


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




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







1)


Store in a well-ventilated place.










2)


Keep cool.










3)


Keep container tightly closed.










4)


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










5)


Keep out of reach of children and pets.










6)


Shelf-life: 24 months




6.   OTHER INFORMATION
-
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
7.1.   Trade name(s), authorisation number and specific composition of each individual product












Trade name(s)


Frend Hand Sanitiser Gel


Market area: EU




Authorisation number


EU-0027707-0031 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


65,3 




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












Trade name(s)


Biogat H-Des


Market area: EU




Authorisation number


EU-0027707-0032 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


70,0 




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












Trade name(s)


Neo-Amisept


Market area: EU




Authorisation number


EU-0027707-0033 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active Substance


67-63-0


200-661-7


63,0 






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

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

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