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)

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)

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

For professional use only.

Products must be shaken before use.

Only apply on dry and visibly clean hands.

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

Avoid contact with eyes.

Keep out of reach of children and pets.

Use only in well-ventilated areas.

For refilling a funnel must be applied.

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

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.

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

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

Do not let product enter drains.

Contact waste disposal services.

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.

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

Store in a well-ventilated place.

Keep cool.

Keep container tightly closed.

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

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

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)

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

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)

For use at room temperature.

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

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).

For use at room temperature.

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

Products must be shaken before use.

Do not apply more than 20 mL/m2.

Used wipes must be disposed in a closed container.

5.2. Risk mitigation measures

Avoid contact with eyes.

For refilling a funnel must be applied.

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

Keep out of reach of children and pets.

Use only in well-ventilated areas.

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

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

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.

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

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

Do not let product enter drains.

Contact waste disposal services.

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

Store in a well-ventilated place.

Keep cool.

Keep container tightly closed.

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

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

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)

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

Comply with the instructions for use.

Products must be shaken before use.

Only apply on dry and visibly clean hands.

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.

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

Avoid contact with eyes.

Use by children only under supervision of an adult.

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

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

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

Call a POISON CENTER or doctor if you feel unwell.

If eye irritation persists: Get medical advice/attention.

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

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

Do not let product enter drains.

Contact waste disposal services.

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

Store in a well-ventilated place.

Keep cool.

Keep container tightly closed.

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

Keep out of reach of children and pets.

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.