Commission Implementing Regulation (EU) 2025/2221 of 31 October 2025 amending Implementing Regulation (EU) 2023/364 as regards administrative changes to the Union authorisation of the biocidal product family IPA Family 1
Date: 2025-10-31
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, biocide, chemical product, decontamination, food safety, market approval, pharmaceutical product








L_202502221EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/2221


7.11.2025







            COMMISSION IMPLEMENTING REGULATION (EU) 2025/2221
of 31 October 2025
         
amending Implementing Regulation (EU) 2023/364 as regards administrative changes to the Union authorisation of the biocidal product family ‘IPA Family 1’
         
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

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


Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 50(2) thereof,

Whereas:







(1)


On 16 February 2023, Commission Implementing Regulation (EU) 2023/364 (2) granted a Union authorisation, under number EU-0028425-0000, to Ecolab Deutschland GmbH for the making available on the market and use of the biocidal product family ‘IPA Family 1’. Annex II to that Implementing Regulation provides the summary of product characteristics for that biocidal product family.












(2)


On 30 November 2023 and 17 December 2024, Ecolab Deutschland GmbH submitted notifications to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013 (3), of administrative changes to the Union authorisation for the biocidal product family ‘IPA Family 1’, as referred to in Title 1 of the Annex to that Regulation. The notifications were recorded in the Register for Biocidal Products (‘the Register’) under case numbers BC-KE090454-43 and BC-JF101949-39. The notified proposed changes to that authorisation concern a clarification of the instructions for use for all products in the family, the addition of new trade names, the removal and addition of the biocidal product formulators and the addition of active substance manufacturers.












(3)


On 24 January 2024 and 16 January 2025, the Agency submitted to the Commission, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013, opinions (4) on the notified administrative changes to the Union authorisation for the biocidal product family ‘IPA Family 1’, together with a revised summary of the biocidal product characteristics. In the opinions, the Agency concludes that the proposed changes are administrative changes as referred to in Article 50(3), point (a), of Regulation (EU) No 528/2012 and as specified in Title 1, Sections 1 and 2, of the Annex to Implementing Regulation (EU) No 354/2013, and that after the implementation of the changes, the conditions of Article 19 of Regulation (EU) No 528/2012 will still be met.












(4)


On 23 January 2025, the Agency transmitted to the Commission a revised summary of the biocidal product characteristics of the Union authorisation for the biocidal product family ‘IPA Family 1’ in all the official languages of the Union, covering all the administrative changes applied for, in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.












(5)


The Commission concurs with the opinions of the Agency and therefore considers it appropriate to amend the Union authorisation for the biocidal product family ‘IPA Family 1’ to introduce the administrative changes requested by Ecolab Deutschland GmbH.












(6)


Except for the amendments regarding the administrative changes, all other information included in the summary of the biocidal product characteristics of ‘IPA Family 1’ as set out in Annex II to Implementing Regulation (EU) 2023/364 remains unchanged.












(7)


In order to enhance clarity and to ease the access of users and interested parties to the consolidated version of the summary of the biocidal product characteristics which is to be published by the Agency, Annex II to Implementing Regulation (EU) 2023/364 should be replaced in its entirety. Due to a change in the format used for the generation of the summary of biocidal product characteristics in the Register in February 2024, the summary of biocidal product characteristics in that Annex should also include some minor editorial and layout changes.












(8)


Implementing Regulation (EU) No 2023/364 should therefore be amended accordingly,





HAS ADOPTED THIS REGULATION:



Article 1
Annex II to Implementing Regulation (EU) No 2023/364 is replaced by the text in the Annex to this Regulation.


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




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 31 October 2025.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(2)  Commission Implementing Regulation (EU) 2023/364 of 16 February 2023 granting a Union authorisation for the biocidal product family ‘IPA Family 1’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 50, 17.2.2023, p. 28, ELI: http://data.europa.eu/eli/reg_impl/2023/364/oj).

(3)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj).

(4)  ECHA Opinions Nos UAD-C-1706275-25-00/F of 24 January 2024 and UAD-C-1790252-35-00/F of 16 January 2025 on the administrative change of the Union authorisation of the biocidal product family ‘IPA Family 1’, https://echa.europa.eu/opinions-on-union-authorisation.




ANNEX
Summary of product characteristics for a biocidal product family
IPA Family 1

Product type(s)

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

Authorisation number EU-0028425-0000

R4BP asset number EU-0028425-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name







Name


IPA Family 1




1.2.   Product type(s)







Product type(s)


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




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


Ecolab Deutschland GmbH




Address


Ecolab Allee 1 40789 Monheim am Rhein Germany




Authorisation number


 


EU-0028425-0000





R4BP asset number



 


EU-0028425-0000




Date of the authorisation


 


9.3.2023




Expiry date of the authorisation


 


28.2.2033




1.4.   Manufacturer(s) of the product







Name of manufacturer


Ecolab Europe GmbH




Address of manufacturer


Richtistrasse, 7 8304 Walliselen Switzerland




Location of manufacturing sites


Ecolab Europe GmbH site 1 Richtistrasse, 7 8304 Walliselen Switzerland













Name of manufacturer


Ecolab Limited




Address of manufacturer


Brunel Way, Baglan Energy Park, SA11 2GA Neath United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites


Ecolab Limited site 1 Brunel Way, Baglan Energy Park, SA11 2GA Neath United Kingdom of Great Britain and Northern Ireland (the)













Name of manufacturer


Ecolab Leeds




Address of manufacturer


Lotherton Way, Garforth, LS25 2JY Leeds United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites


Ecolab Leeds site 1 Lotherton Way, Garforth, LS25 2JY Leeds United Kingdom of Great Britain and Northern Ireland (the)













Name of manufacturer


Esoform S.p.A.




Address of manufacturer


Viale del Lavoro 10, 45100 Rovigo Italy




Location of manufacturing sites


Esoform S.p.A. site 1 Viale del Lavoro 10, 45100 Rovigo Italy













Name of manufacturer


Nalco Deutschland Manufacturing GmbH und Co.KG




Address of manufacturer


Justus-von-Liebig-Str. 11 D-64584 Biebesheim Germany




Location of manufacturing sites


Nalco Deutschland Manufacturing GmbH und Co.KG site 1 Justus-von-Liebig-Str. 11 D-64584 Biebesheim Germany













Name of manufacturer


Ecolab NETHERLANDS BV




Address of manufacturer


Brugwal 11, 3432NZ Nieuwegein Netherlands (the)




Location of manufacturing sites


Ecolab NETHERLANDS BV site 1 Brugwal 11, 3432NZ Nieuwegein Netherlands (the)













Name of manufacturer


Ecolab Weavergate




Address of manufacturer


Winnington Avenue CW8 3AA Northwich Cheshire United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites


Ecolab Weavergate site 1 Winnington Avenue CW8 3AA Northwich Cheshire United Kingdom of Great Britain and Northern Ireland (the)













Name of manufacturer


Ecolab Mullingar, Ireland




Address of manufacturer


Forest Park, Zone C Mullingar Ind. Estate, - Mullingar, Co. Westmeath, Ireland




Location of manufacturing sites


Ecolab Mullingar, Ireland site 1 Forest Park, Zone C Mullingar Ind. Estate, - Mullingar, Co. Westmeath, Ireland













Name of manufacturer


Ecolab d.o.o.




Address of manufacturer


Vajngerlova 4 2000 Maribor Slovenia




Location of manufacturing sites


Ecolab d.o.o. site 1 Vajngerlova 4 2000 Maribor Slovenia













Name of manufacturer


Ecolab Rozzano, Italy




Address of manufacturer


Via A. Grandi 9/11, 20089 Rozzano (MI) Italy




Location of manufacturing sites


Ecolab Rozzano, Italy site 1 Via A. Grandi 9/11, 20089 Rozzano (MI) Italy













Name of manufacturer


Ecolab B.V.B.A




Address of manufacturer


Havenlaan 4 3980 Tessenderlo Belgium




Location of manufacturing sites


Ecolab B.V.B.A site 1 Havenlaan 4 3980 Tessenderlo Belgium













Name of manufacturer


Nalco Española Manufacturing, SLU




Address of manufacturer


C/Tramuntana s/n Polígono Industrial de Celrà 17460 Celrà Spain




Location of manufacturing sites


Nalco Española Manufacturing, SLU site 1 C/Tramuntana s/n Polígono Industrial de Celrà 17460 Celrà Spain













Name of manufacturer


Ecolab production France SAS




Address of manufacturer


BP509, Avenue de Général Patton 51006 Châlons-en-Champagne France




Location of manufacturing sites


Ecolab production France SAS site 1 BP509, Avenue de Général Patton 51006 Châlons-en-Champagne France













Name of manufacturer


Ecolab Mandra, Greece




Address of manufacturer


25km Old National Road Athens- Theve, - Mandra Attica Greece




Location of manufacturing sites


Ecolab Mandra, Greece site 1 25km Old National Road Athens- Theve, - Mandra Attica Greece













Name of manufacturer


NALCO FINLAND MANUFACTURING OY




Address of manufacturer


Kivikummuntie 1, FIN-07955 Tesjoki Finland




Location of manufacturing sites


NALCO FINLAND MANUFACTURING OY site 1 Kivikummuntie 1, FIN-07955 Tesjoki Finland













Name of manufacturer


Manufacturing Plant Cisterna Nalco




Address of manufacturer


Via Ninfina II 4012 Cisterna Di Latina, Italy




Location of manufacturing sites


Manufacturing Plant Cisterna Nalco site 1 Via Ninfina II 4012 Cisterna Di Latina Italy













Name of manufacturer


Manufacturing Plant Fawley Nalco




Address of manufacturer


One buisness center 1180 SO45 3NP Hardley Hants United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites


Manufacturing Plant Fawley Nalco site 1 One buisness center 1180 SO45 3NP Hardley Hants United Kingdom of Great Britain and Northern Ireland (the)













Name of manufacturer


Nalco Champion Plant, Tooling Plant, Aberdeen Nalco




Address of manufacturer


Minto Avenue, Alten Industrial Estate AB12 3JZ Aberdeen United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites


Nalco Champion Plant, Tooling Plant, Aberdeen Nalco site 1 Minto Avenue, Alten Industrial Estate AB12 3JZ Aberdeen United Kingdom of Great Britain and Northern Ireland (the)













Name of manufacturer


Microtek Medical B.V.




Address of manufacturer


Hekkehorst, 24 7207 BN Zutphen Netherlands (the)




Location of manufacturing sites


Microtek Medical B.V. site 1 Hekkehorst, 24 7207 BN Zutphen Netherlands (the)













Name of manufacturer


Microtek Medical Malta Ltd.




Address of manufacturer


Sorbonne Centre F20 Mosta Technopark MST 3000 Mosta Malta




Location of manufacturing sites


Microtek Medical Malta Ltd. site 1 Sorbonne Centre F20 Mosta Technopark MST 3000 Mosta Malta













Name of manufacturer


Innovate GmbH




Address of manufacturer


Am Hohen Stein, 11 06618 Naumburg Germany




Location of manufacturing sites


Innovate GmbH site 1 Am Hohen Stein, 11 06618 Naumburg Germany













Name of manufacturer


CHRISTEYNS FRANCE S.A.




Address of manufacturer


31 rue de la Maladrie 44120 Vertou France




Location of manufacturing sites


CHRISTEYNS FRANCE S.A. site 1 54 avenue de la Plaine - ZI 13106 Rousset France













Name of manufacturer


Techtex




Address of manufacturer


Units 7 &amp; 8, Rhodes Business Park, Silbum Way M24 4NE Middelton, Manchester United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites


Techtex site 1 Units 7 & 8, Rhodes Business Park, Silbum Way M24 4NE Middelton, Manchester United Kingdom of Great Britain and Northern Ireland (the)













Name of manufacturer


Technical Textile Services Ltd




Address of manufacturer


Unit 4, Rhodes Business Park, Silburn Way M24 4NE Middleton, Manchester United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites


Technical Textile Services Ltd Unit 4, Rhodes Business Park, Silburn Way M24 4NE Middleton, Manchester United Kingdom of Great Britain and Northern Ireland (the)













Name of manufacturer


Pal International Limited




Address of manufacturer


Unit 3 Mountpark, Victoria Road LE67 1FA Ellistown, Coalville United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites


Pal International Limited Unit 3 Mountpark, Victoria Road LE67 1FA Ellistown, Coalville United Kingdom of Great Britain and Northern Ireland (the)













Name of manufacturer


CID LINES NV




Address of manufacturer


Waterpoortstraat 2 8900 Ieper Belgium




Location of manufacturing sites


CID LINES NV Waterpoortstraat 2 8900 Ieper Belgium













Name of manufacturer


LABORATOIRES ANIOS




Address of manufacturer


3330 Rue de Lille 59262 Sainghin-en-Mélantois France




Location of manufacturing sites


LABORATOIRES ANIOS 3330 Rue de Lille 59262 Sainghin-en-Mélantois France




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







Active substance


Propan-2-ol




Name of manufacturer


Ineos Solvents Germany GmbH




Address of manufacturer


Römerstrasse 733, D-47443 Moers Germany




Location of manufacturing sites







Ineos Solvents Germany GmbH site 1 Shamrockstrasse 88 D-44623 Herne Germany




Ineos Solvents Germany GmbH site 2 Romestrasse, 733, D-47443 Moers Germany

















Active substance


Propan-2-ol




Name of manufacturer


Shell Chemicals Europe B.V.




Address of manufacturer


Postbus 2334 3000 CH Rotterdam Netherlands (the)




Location of manufacturing sites


Shell Chemicals Europe B.V. site 1 Chemie BV/Shell Nederland Raffinaderij B.V., Vondelingenweg 601 3196 KK Rotterdam-Pernis, Netherlands (the)













Active substance


Propan-2-ol




Name of manufacturer


ExxonMobil Chemical Europe




Address of manufacturer


Hermeslaan 2 1831 Machelen Belgium




Location of manufacturing sites







ExxonMobil Chemical Europe site 1 Fawley Refinery and Petrochemical Plant, Fawley SO45 1TX Southampton United Kingdom of Great Britain and Northern Ireland (the)




ExxonMobil Chemical Europe site 2 Baton Rouge Chemical Plant 4999 Scenic Highway 70805-3359 LA United States (the)

















Active substance


Propan-2-ol




Name of manufacturer


Brenntag N.V.




Address of manufacturer


Nijverheidslaan, 38 8540 Deerlijk Belgium




Location of manufacturing sites







Shell Energy and Chemicals Park Rotterdam Shell Nederland Chemie BV/Shell Nederland Raffinaderij B.V., Vondelingenweg 601 3196 KK Rotterdam-Pernis Netherlands (the)




ExxonMobil Baton Rouge Refinery 4045 Scenic Highway Baton Rouge 70805 LA United States (the)

















Active substance


Propan-2-ol




Name of manufacturer


UNIVAR




Address of manufacturer


Steuber Drive M44 5AL Manchester United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites


ExxonMobil Chemicals Fawley Refinery and Petrochemical Plant, Fawley SO45 1TX Southampton United Kingdom of Great Britain and Northern Ireland (the)




2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the family











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


30,3  - 65,66  % (w/w)




2.2.   Type(s) of formulation







Formulation type(s)


AE Aerosol dispenser
AL Any other liquid
XX – Ready to use wipe impregnated with water based liquid




PART II

SECOND INFORMATION LEVEL META SPC(S)

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier







Identifier


Meta SPC: Meta-SPC 1.1




1.2.   Suffix to the authorisation number







Number


1-1




1.3.   Product type(s)







Product type(s)


PT02: Disinfectants and algaecides not intended for direct application to humans or animals




2.   META SPC 1 COMPOSITION

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











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


60,61  - 65,66  % (w/w)




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







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1







Hazard statements


H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.




Precautionary statements


P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P280: Wear eye protection.
P280: Wear face protection.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Use # 1.1 – Disinfection of surfaces in cleanrooms by spraying or mopping.







Product type


PT02: Disinfectants and algaecides not intended for direct application to humans or animals




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Scientific name: no data
Common name: fungi
Development stage: no data
Scientific name: no data
Common name: Enveloped viruses
Development stage: no data




Field(s) of use


indoor use
Disinfection of cleanroom hard non-porous surfaces in life sciences industry.




Application method(s)


Method: Trigger spraying or mopping
Detailed description:
Direct application onto surfaces by trigger spraying followed by wiping with a dry wipe for distribution or mopping.




Application rate(s) and frequency


Application Rate:
c.a. 18 ml/m2

ready to use product
Number and timing of application:
As required




Category(ies) of users


professional




Pack sizes and packaging material


0,5 liter - 10 liters Polyvinylpyrrolidone (PVP) or (High density polyetheylene (HDPE) bottle / container (with and without trigger spray)




4.1.1.   Use-specific instructions for use

Clean and dry surfaces prior to disinfection.
Application by trigger spraying directly onto the surface: Open the nozzle before use. For optimum results hold bottle upright and apply from a distance of 10 cm to 20 cm. Ensure complete wetting of the surfaces (18 ml/m2, corresponding to 20 strokes/m2) followed by wiping with a dry wipe for distribution. Allow to take effect for 5 minutes for bacteria, yeast and enveloped viruses and 15 minutes for fungi. Always close the nozzle after use. Do not transfer the product to a trigger sprayer, but apply from a package delivered with trigger sprayer.
Application on surfaces by Mopping: Impregnate the clean mop with the liquid using a mop bucket and apply to the surface to be disinfected. Ensure complete wetting of the surface (18 mL/m2). Allow to take effect for 5 minutes for bacteria, yeast and enveloped viruses and 15 minutes for fungi. No additional wiping necessary.
Do not mix product with other products. Do not pour any unused product back into the original container.
4.1.2.   Use-specific risk mitigation measures

Avoid contact with eyes.
Gloves, eye protection and respiratory protection equipment (RPE) of protection factor of 10 should be worn during mopping. Unprotected personnel should not be present in the room during disinfection by mopping.
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



Potential Health Effects



Eyes – Causes serious eye irritation.

Skin – Health injuries are not known or expected under normal use.

Ingestion – Health injuries are not known or expected under normal use.

Inhalation – Inhalation may cause central nervous system effects.

Chronic Exposure - Health injuries are not known or expected under normal use.


First Aid Measures



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 ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

IF SWALLOWED : Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. 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
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use (5.4).
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 (5.5).
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1.   Instructions for use

Please refer to specific instructions for use for meta-SPC 1
5.2.   Risk mitigation measures

Please refer to specific Risk mitigation measures for meta-SPC 1
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to specific information for meta-SPC 1
5.4.   Instructions for safe disposal of the product and its packaging



Product


Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.


Contaminated packaging


Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national, and/or international regulations.


Product residues


Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.
Dispose of unused product, its packaging and all other waste, in accordance with local regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Store away from direct sunlight and at temperature between 0°C to 25°C
Shelf life: 24 months
6.   OTHER INFORMATION

Safety data sheet and technical sheet available for professional users on request.
AEL acute/medium-term/long-term 17,9 mg/kg body weight (bw)/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report on Propan-2-ol in PT2 – Germany – (January 2015).
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)


Klercide 70/30 IPA


Market area: EU




Klercide non-sterile 70/30 IPA


Market area: EU




Klercide 70/30 IPA non-sterile


Market area: EU




Authorisation number


 


EU-0028425-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


63,27  % (w/w)




1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier







Identifier


Meta SPC: Meta-SPC 1.2




1.2.   Suffix to the authorisation number







Number


1-2




1.3.   Product type(s)







Product type(s)


PT02: Disinfectants and algaecides not intended for direct application to humans or animals




2.   META SPC 2 COMPOSITION

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











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


60,61  - 65,66  % (w/w)




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







Formulation type(s)


XX – Ready to use wipe impregnated with water based liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2







Hazard statements


H225: Highly flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.




Precautionary statements


P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Use # 2.1 – Disinfection of surfaces in cleanroom by wiping







Product type


PT02: Disinfectants and algaecides not intended for direct application to humans or animals




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Scientific name: no data
Common name: fungi
Development stage: no data
Scientific name: no data
Common name: Enveloped viruses
Development stage: no data




Field(s) of use


indoor use
Disinfection of cleanroom hard non-porous surfaces in life sciences industry by wiping.




Application method(s)


Method: Wiping
Detailed description:
Direct application onto surfaces by wiping with pre-wetted wipes.




Application rate(s) and frequency


Application Rate:
c.a. 10 ml/m2

ready to use product
Number and timing of application:
Tub (200 wipes/pack, 230×200, Synthetic/cellulose blend): c.a. 0,13 m2 can be disinfected with 1 wipe
Tub (100 wipes/pack, 200×230, Synthetic/cellulose blend): c.a. 0,23 m2 can be disinfected with 1 wipe
Mop (10 wipes/pack, 420×250, Polyester/cellulose): c.a. 1,1 m2 can be disinfected with 1 wipe
Pouch (15 wipes/pack, 200×200, Polyester/cellulose): c.a. 0,33 m2 can be disinfected with 1 wipe
Pouch (10 wipes/pack, 200×200, 100% polyester): c.a. 0,51 m2 can be disinfected with 1 wipe
Pouch (15 wipes/pack, 300×300, Polyester/cellulose): c.a. 0,47 m2 can be disinfected with 1 wipe
Pouch (10 wipes/pack, 300×300, 100% polyester): c.a. 0,73 m2 can be disinfected with 1 wipe




Category(ies) of users


professional




Pack sizes and packaging material


Tub (HDPE) (100-200 wipes/pack, 200×230, Synthetic/cellulose blend)
Pouch (10-30 wipes/pack, 200×200, Polyester/cellulose, 100% polyester)
Pouch (10-30 wipes/pack, 300×300, Polyester/cellulose, 100% polyester)
Mop wipe (10-30 wipes/pack, 420×250, Polyester/cellulose)




4.1.1.   Use-specific instructions for use

Clean and dry surfaces prior to disinfection.
Wiping: Wipe surface to be disinfected. Use wipe once. Ensure complete wetting of the surface (10 ml/m2).
About 0,13-1,1 m2 can be disinfected with 1 wipe depending on the wipe.
Allow to take effect for 5 minutes for bacteria, yeast and enveloped viruses and 15 minutes for fungi. Dispose of the wipes in the appropriate closed waste bin immediately after use. No additional wiping necessary.
For multipack wipes, close the package after opening.
Do not mix with other products.
4.1.2.   Use-specific risk mitigation measures

-
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



Potential Health Effects



Eyes – Causes serious eye irritation.

Skin – Health injuries are not known or expected under normal use.

Ingestion – Health injuries are not known or expected under normal use.

Inhalation – Inhalation may cause central nervous system effects.

Chronic Exposure – Health injuries are not known or expected under normal use.


First Aid Measures



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 ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

IF SWALLOWED : Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. 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
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use (5.4).
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 (5.5).
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 2

5.1.   Instructions for use

Please refer to specific instructions for use for meta-SPC 2
5.2.   Risk mitigation measures

Please refer to specific risk mitigation measures for meta-SPC 2
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to specific information for meta-SPC 2
5.4.   Instructions for safe disposal of the product and its packaging



Product


Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.


Contaminated packaging


Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national and/or international regulations.


Product residues


Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.
Dispose of unused product, its packaging and all other waste, in accordance with local regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Store away from direct sunlight and at temperature between 0°C to 25°C
Shelf life: 24 months
6.   OTHER INFORMATION

Safety data sheet and technical sheet available for professional users on request.
AEL acute/medium-term/long-term 17,9 mg/kg bw/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report of Propan-2-ol in PT2 Germany – (January 2015).
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)


Klerwipe 70/30 IPA


Market area: EU




Klerwipe non-sterile 70/30 IPA


Market area: EU




Klerwipe 70/30 IPA non-sterile


Market area: EU




Authorisation number


 


EU-0028425-0002 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


63,27  % (w/w)




1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier







Identifier


Meta SPC: Meta-SPC 1.3




1.2.   Suffix to the authorisation number







Number


1-3




1.3.   Product type(s)







Product type(s)


PT02: Disinfectants and algaecides not intended for direct application to humans or animals




2.   META SPC 3 COMPOSITION

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











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


60,61  - 65,66  % (w/w)




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







Formulation type(s)


AE Aerosol dispenser




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3







Hazard statements


H222 : Extremely flammable aerosol.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
H229: Pressurised container: May burst if heated
EUH066: Repeated exposure may cause skin dryness or cracking.




Precautionary statements


P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P280: Wear eye protection.
P280: Wear face protection.
P211: Do not spray on an open flame or other ignition source.
P251: Do not pierce or burn, even after use.
P410+P412: Protect from sunlight. Do no expose to temperatures exceeding 50°C/ 122°F.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Use # 3.1 – Disinfection of surfaces in cleanroom by aerosols







Product type


PT02: Disinfectants and algaecides not intended for direct application to humans or animals




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data
Scientific name: no data
Common name: fungi
Development stage: no data
Scientific name: no data
Common name: Enveloped viruses
Development stage: no data




Field(s) of use


indoor use
Disinfection of cleanroom hard non-porous surfaces in life sciences industry.




Application method(s)


Method: Aerosol spraying
Detailed description:
Direct application onto surfaces by aerosol spraying followed by wiping with a dry wipe for distribution.




Application rate(s) and frequency


Application Rate:
c.a. 18 ml/m2

ready to use product
Number and timing of application:
As required




Category(ies) of users


professional




Pack sizes and packaging material


0,2 liter – 0,5 liter aluminium can




4.1.1.   Use-specific instructions for use

Clean and dry surfaces prior to disinfection.
Application by aerosol spraying: For optimum results hold can upright and apply from a distance of 10 cm to 20 cm. Ensure complete wetting of the surfaces (18 ml/m2, corresponding to 7,2 seconds/m2 spraying) followed by wiping with a dry wipe for distribution. Allow to take effect for 5 minutes for bacteria, yeast and enveloped viruses and 15 minutes for fungi.
Do not mix product with other products.
4.1.2.   Use-specific risk mitigation measures

Avoid contact with eyes.
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



Potential Health Effects



Eyes – Causes serious eye irritation.

Skin – Health injuries are not known or expected under normal use.

Ingestion – Health injuries are not known or expected under normal use.

Inhalation – Inhalation may cause central nervous system effects. Intentional misuse by deliberate inhalation may be harmful or fatal.

Chronic Exposure – Health injuries are not known or expected under normal use.


First Aid Measures



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 ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

IF SWALLOWED : Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. 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
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use (5.4).
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 (5.5).
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 3

5.1.   Instructions for use

Please refer to specific instructions of use for meta-SPC 3
5.2.   Risk mitigation measures

Please refer to specific risk mitigation measures for meta-SPC 3
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to specific information for meta-SPC 3
5.4.   Instructions for safe disposal of the product and its packaging



Product


Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.


Contaminated packaging


Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national and/or international regulations.


Product residues


Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.
Dispose of unused product, its packaging and all other waste, in accordance with local regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Store away from direct sunlight and at temperature between 0°C to 25°C
Shelf life: 24 months
6.   OTHER INFORMATION

Safety data sheet and technical sheet available for professional users on request.
AEL acute/medium-term/long-term 17,9 mg/kg bw/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report of Propan-2-ol in PT2 – Germany – (January 2015).
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)


Klercide 70/30 IPA Aerosol


Market area: EU




Authorisation number


 


EU-0028425-0003 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


63,269  % (w/w)




1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier







Identifier


Meta SPC: Meta-SPC 1.4




1.2.   Suffix to the authorisation number







Number


1-4




1.3.   Product type(s)







Product type(s)


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




2.   META SPC 4 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 4











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


30,3  - 30,3  % (w/w)




2.2.   Type(s) of formulation of the meta SPC 4







Formulation type(s)


XX - Ready to use wipe impregnated with water based liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4







Hazard statements


H226: Flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.




Precautionary statements


P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Use # 4.1 – Disinfection of non-food and food contact surfaces by pre-wetted wipes







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data




Field(s) of use


indoor use
Disinfection of food contact and non-food contact hard non-porous surfaces in: Commercial kitchens, Catering, Food processing and Food Retail, Canteen, Bathrooms and Restrooms in hotels, restaurants, stores, schools, offices.




Application method(s)


Method: Wiping
Detailed description:
Direct application onto hard non-porous surfaces by wiping.




Application rate(s) and frequency


Application Rate:
c.a. 10 ml/m2 at room temperature
ready to use product
Number and timing of application:
Wiping with two superposed wipes.
About 0,074-0,222 m2 can be disinfected with two superposed wipes depending on the size of wipe used.




Category(ies) of users


professional




Pack sizes and packaging material


Container (PP) (100 wipes 130×210)
Container (HDPE) (150 wipes 180×300)
Bucket (PP) (1500 wipes 150×210)
Pouch (PET/PE) (200 wipes 130×210)
Wipe material (all packagings): blend of Pulp, Polyester, Binder




4.1.1.   Use-specific instructions for use

Wiping: Clean and dry surfaces prior to disinfection.
Wipe surface to be disinfected with two superposed wipes. Use the wipes once. For optimum results ensure complete wetting of the surface (10 ml/m2 ), about 0,074-0,222 m2 can be disinfected with two superposed wipes depending on the size of wipe used. Allow to take effect for 15 minutes for bacteria and yeast. Dispose the wipes in the appropriate closed waste bin immediately after use. No additional wiping necessary.
For multipack wipes, close the package after opening.
Do not mix product with other products.
4.1.2.   Use-specific risk mitigation measures

-
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



Potential Health Effects



Eyes – Causes serious eye irritation.

Skin – Health injuries are not known or expected under normal use.

Ingestion – Health injuries are not known or expected under normal use.

Inhalation – Inhalation may cause central nervous system effects.

Chronic Exposure – Health injuries are not known or expected under normal use.


First Aid Measures



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 ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

IF SWALLOWED : Rinse mouth. Give something to drink, if exposed person isable to swallow. Do NOT induce vomiting. 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.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use (5.4).
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 (5.5).
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 4

5.1.   Instructions for use

Please refer to specific instructions of use for meta-SPC 4
5.2.   Risk mitigation measures

Please refer to specific risk mitigation measures for meta-SPC 4
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to specific information for meta-SPC 4
5.4.   Instructions for safe disposal of the product and its packaging



Product


Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.


Contaminated packaging


Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national and/or international regulations.


Product residues


Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.
Dispose of unused product, its packaging and all other waste, in accordance with local regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Store away from direct sunlight and at temperature between 0°C to 25°C
Shelf life: 24 months
6.   OTHER INFORMATION

Safety data sheet and technical sheet available for professional users on request.
AEL acute/medium-term/long-term 17,9 mg/kg bw/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report of Propan-2-ol in PT2 – Germany – (January 2015).
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4

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













Trade name(s)


Eco-Bac Wipes


Market area: EU




Sirafan Bac Wipes


Market area: EU




Authorisation number


 


EU-0028425-0004 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


30,3  % (w/w)




1.   META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier







Identifier


Meta SPC: Meta-SPC 1.5




1.2.   Suffix to the authorisation number







Number


1-5




1.3.   Product type(s)







Product type(s)


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




2.   META SPC 5 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 5











Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


30,3  - 30,3  % (w/w)




2.2.   Type(s) of formulation of the meta SPC 5







Formulation type(s)


AL Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5







Hazard statements


H226: Flammable liquid and vapour.
H319: Causes serious eye irritation.
H336: May cause drowsiness or dizziness.
EUH066: Repeated exposure may cause skin dryness or cracking.




Precautionary statements


P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P280: Wear eye protection.
P280: Wear face protection.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Use # 5.1 – Disinfection of non-food and food contact surfaces by trigger spray







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Scientific name: no data
Common name: Bacteria
Development stage: no data
Scientific name: no data
Common name: Yeasts
Development stage: no data




Field(s) of use


indoor use
Disinfection of food contact and non-food contact hard non-porous surfaces in: Commercial kitchens, Catering, Food processing and Food Retail, Canteen, Bathrooms and Restrooms in hotels, restaurants, stores, schools, offices.




Application method(s)


Method: Trigger spraying
Detailed description:
Direct application onto hard non-porous surfaces by trigger spraying.




Application rate(s) and frequency


Application Rate:
c.a. 18 ml/m2 at room temperature
ready to use product
Number and timing of application:
As required




Category(ies) of users


professional




Pack sizes and packaging material


0,5 liter – 10 liter HDPE container (with trigger spray)




4.1.1.   Use-specific instructions for use

Application by trigger spraying: Open the nozzle before use. For optimum results hold bottle upright and apply from a distance of 10 cm to 20 cm. Ensure complete wetting of the surfaces (18 ml/m2, corresponding to 29 strokes/m2). Allow to take effect for 30 seconds for bacteria and yeast. Always close the nozzle after use.
Do not mix product with other products. Do not pour any unused product back into the original container.
4.1.2.   Use-specific risk mitigation measures

Avoid contact with eyes.
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



Potential Health Effects



Eyes – Causes serious eye irritation.

Skin – Health injuries are not known or expected under normal use.

Ingestion – Health injuries are not known or expected under normal use.

Inhalation – Inhalation may cause central nervous system effects.

Chronic Exposure – Health injuries are not known or expected under normal use.


First Aid Measures



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 ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

IF SWALLOWED : Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. 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
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use (5.4).
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 (5.5).
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 5

5.1.   Instructions for use

Please refer to specific instructions of use for meta-SPC 5
5.2.   Risk mitigation measures

Please refer to specific risk mitigation measures for meta-SPC 5
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to specific information for meta-SPC 5
5.4.   Instructions for safe disposal of the product and its packaging



Product


Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.


Contaminated packaging


Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national and/or international regulations.


Product residues


Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.
Dispose of unused product, its packaging and all other waste, in accordance with local regulations.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Store away from direct sunlight and at temperature between 0°C to 25°C
Shelf life: 24 months
6.   OTHER INFORMATION

Safety data sheet and technical sheet available for professional users on request.
AEL acute/medium-term/long-term 17,9 mg/kg bw/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report of Propan-2-ol in PT2 – Germany – (January 2015).
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5

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













Trade name(s)


Sirafan Speed-FR


Market area: EU




Authorisation number


 


EU-0028425-0005 1-5




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Propan-2-ol


 


Active substance


67-63-0


200-661-7


30,3  % (w/w)







ELI: http://data.europa.eu/eli/reg_impl/2025/2221/oj
ISSN 1977-0677 (electronic edition)